Inspections, Compliance, Enforcement, and Criminal Investigations



6-2-1 - Purpose
6-2-2 - General Guidelines
6-2-3 - Definitions
6-2-4 - General Considerations
6-2-5 - Adequate Notice Preceding Injunction Actions
6-2-6 - Prerequisites for a TRO or Preliminary Injunction
6-2-7 - Refreshing Evidence - Updating Inspections
6-2-8 - Approval Process for Seizure and Injunction Cases
6-2-9 - Responsibilities for Injunction Actions
6-2-10 - Cover Letter to DOJ
6-2-11 - Complaint for Injunction
6-2-12 - Declarations
6-2-13 - Consent Decree
6-2-14 - Costs of Supervision
6-2-15 - Compliance Follow-Up
6-2-16 - Vacating Injunctions
6-2-17 - Issuing Press Releases


6-2-1 - Purpose

The purpose of this section is to provide instructions and define responsibilities for those field and headquarters units involved in the development, preparation, processing, and follow-up of injunctions.

6-2-2 - General Guidelines

An injunction is a civil judicial process initiated to stop or prevent violation of the law, such as to halt the flow of violative products in interstate commerce, and to correct the conditions that caused the violation to occur. See 21 U.S.C. 332; Rule 65, Rules of Civil Procedure. If a firm has a history of violations, and has promised correction in the past, but has not made the corrections, the injunction is more likely to succeed. However, the freshness of the evidence is critical.

For an injunction action to be credible in the eyes of the Department of Justice (DOJ), the U.S. Attorney, and the court, the evidence must be current. Timeliness is an important factor when considering an injunction action, with or without a Motion for Preliminary Injunction, or a temporary restraining order (TRO). However, case quality and credibility must not be sacrificed to meet guideline time frames. The purpose of the guideline time frames is to limit, as much as can reasonably be expected, the need to update evidence. (Updating entails extra work at all levels of the case development and review process and, more importantly, delays obtaining an injunction, which is intended to stop violations that adversely affect the safety or quality of products in commerce.)

Once a complaint for injunction is filed by the United States, a hearing may be placed on the court calendar at any time with extremely short notice. It is imperative that the district compliance officer maintain close contact with the OCC attorney and the Assistant U.S. Attorney to be aware of any hearings on FDA actions.

When an injunction is granted, FDA has a continuing duty to monitor the injunction and to advise the court if the defendants fail to obey the terms of the decree.

Should the decree be violated, the agency must consider a civil or criminal contempt of court, or other regulatory action, in as timely a manner as used in initiating the injunction. It is, therefore, mandatory that FDA personnel responsible for initiating injunctions also adhere to the implementation procedure in “Compliance Follow-up.”

6-2-3 - Definitions

  1. Temporary Restraining Order

    Temporary restraining orders are court enforced orders entered to control an emergency situation. A TRO seeks immediate, temporary relief (for a period of 10 days, which may be extended for 10 additional days) prior to the hearing for preliminary injunction.

    FDA recommends a TRO when the agency believes that the violation is so serious that it must be controlled immediately. A request for a TRO also has the effect of expediting review of the underlying injunction case by the court. An inadequately documented TRO request may result in the court viewing the entire injunction action as lacking credibility.

    At the court's discretion, the TRO request may be subjected to a hearing, which may be ex parte (without the defendants’ presence), by reviewing the documents and questioning government counsel, the FDA investigator, the district compliance officer, or other FDA personnel.

  2. Preliminary Injunction

    Whether or not a TRO has been obtained, a Motion for Preliminary Injunction is subject to a full hearing in which (1) evidence by affidavit, or (2) testimony of witnesses is presented, depending on the practice of the court. Once the motion is granted, or the defendants consent to the entry of a decree, the preliminary injunction is in effect.

    A preliminary injunction may stand indefinitely on the court record until the case is settled or a permanent injunction has been entered, after trial or further briefing. A preliminary injunction may be dismissed, or further proceedings for permanent injunction may be set by the court, at the request of either party, at any time.

  3. Permanent Injunction

    A Decree of Permanent Injunction may be entered at any time after the complaint is filed, either following a hearing or as a result of a negotiated settlement. Defendants in an injunction proceeding may consent to a Decree of Permanent Injunction just as they consent to a Consent Decree of Condemnation in a seizure action.

    Should the defendant not consent to such a decree, a trial is held in which, to prevail, the government must prove each element of its case by a preponderance of the evidence. As its name implies, a Decree of Permanent Injunction remains in effect until it is dissolved by an order of the court.

6-2-4 - General Considerations

  1. When An Injunction May Be Considered

    An injunction may be considered for any significant out-of-compliance circumstance, but particularly when a health hazard has been identified. Proceeding by injunction does not preclude institution of additional or concurrent action such as recall, publicity, seizures, embargo by cooperating officials, or criminal prosecution.

    In considering an injunction, the agency must evaluate the seriousness of the offense, the actual or potential impact of the offense on the public, whether other possible actions could be as effective or more effective, the need for prompt judicial action, and whether it will be able to demonstrate the likelihood of the continuance of the violation in the absence of a court order. Injunction will be the action of choice when:

    1. There is a current and definite health hazard or a gross consumer deception requiring immediate action to stop the violative practice and a seizure is impractical; or
    2. There are significant amounts of violative products owned by the same person, a voluntary recall by the firm was refused or is significantly inadequate to protect the public, and a seizure is impractical or uneconomical; or
    3. There are long-standing (chronic) violative practices that have not produced a health hazard or consumer fraud, but which have not been corrected through use of voluntary or other regulatory approaches.
    4. With respect to a and b above, it is helpful, but not mandatory, to show that there has been a history of prior violations, and that previous attempts to correct them through alternative warnings or sanctions have not been effective. A showing of a violative history should be made whenever possible, but especially in those cases where an imminent danger to health cannot be alleged.
  2. Multi-District Injunctions

    When similar violative practices are found at two or more facilities under the same corporate management, the home district where the corporate office is located should evaluate the compliance histories of corporate facilities located in other FDA districts to determine whether there are patterns of violations or trends that indicate the presence of systemic problems that should be addressed on a multi-district basis.

    The Centers, districts, and Office of Enforcement (OE) have a significant role in assessing these situations and in developing and coordinating a regulatory approach. The initial and continuing roles of the various offices in multi-district injunctions are described in the procedures titled “Injunctions (Multi-district).”

    See exhibit 6-11. These procedures were developed to facilitate planning, and the timely preparation, processing and review of these types of cases. They must be followed as soon as a potential multi-district injunction is identified by a district or Center. At its discretion, the recommending district may invoke these procedures for a single district injunction involving multiple Centers.

6-2-5 - Adequate Notice Preceding Injunction Actions

FDA strengthens its injunction actions by demonstrating in the complaint that FDA made and has documented a conscious effort to get the objectionable products or practices corrected without court involvement. For example, the defendants were notified of the violations (by letter, FDA 483, meeting, telephone call) and, despite having an opportunity to correct the violations, failed to do so. Prior notice is not a legal requirement, but can demonstrate a defendant’s resistance to compliance and enhance the agency’s request for court intervention.

Although there is no legal requirement to name individuals in complaints for injunction, the agency believes that by doing so, individuals not named in the complaint will be more inclined to prevent violations from occurring in the first instance (general deterrence) and that named individuals will be more inclined to take immediate and active interest in seeing that the violation ceases (specific deterrence). Also, the identification of the responsible persons will prevent their pretense that they were not subject to the injunction, and will help prevent circumvention of the injunction by changing the name of the corporation. Therefore, the individuals who have the authority and responsibility to correct or prevent the violations should be named as defendants.

During its normal case-development process, FDA will therefore strive to identify the individuals with the authority to take corrective actions and prevent future violations and to develop evidence proving the individuals’ authority and responsibility. Such individuals may be located at the sites of the actual or potential violation, at other offices and sites, or both. When there are questions concerning individual responsibility during the review process, assignments should be issued requesting further documentation. One principal purpose of these efforts is to ensure that individuals standing in positions of authority with respect to actual or potential violative conditions will be provided with adequate notice concerning the evidence found by FDA. The management officials believed by FDA to have the highest level of authority in an organization should always receive notice.

  1. Methods of Giving Notice

    Notice may take a variety of forms including letters and notices from other government agencies, recalls, issuance of FDA 483s, post-inspection discussions, meetings, and telephone calls. All persons receiving notice and the circumstances (date, time, place, and substance) of notice should be documented. Recognizing that firms under FDA jurisdiction include those ranging from owner-operator to large conglomerates and that the nature of violations will vary; what is deemed adequate notice will differ from case to case. Factors to be considered in determining adequacy include, but are not limited to, complexity of the organizational structure, duties and authority of persons believed to be responsible, nature of the violation, compliance history, and the length of time elapsed between notice and filing of the case. Also, see Chapter 10 “Prior Notice” and “Regulatory Meetings.”

    The factors listed below will apply in determining the adequacy of notice. Agency records should show that sometime during case development:

    1. The individuals with authority to prevent or correct violations have been given appropriate notice of the general conditions that are violative.
    2. There is sufficient information to conclude that proper action to correct the violations has not been taken or will not be taken promptly.
    3. Reasonable efforts on the part of the agency were made and documented to get the objectionable product and practice corrected without court involvement. Any attempts by the proposed defendants to correct the problem should also be reported.

    NOTE: There may be cases where exceptions to the need to show notice through factors a-c are justified. Justification for such exceptions must accompany the case submission.

6-2-6 - Prerequisites for a TRO or Preliminary Injunction

Note: Injunctions that include requests for a Temporary Restraining Order (TRO) have the highest priority ranking of all legal actions. Ensuring that criteria for TROs have been met and that strategies will be developed to halt the violative conduct usually requires knowledge of FDA issues and experience. For this reason, it is recommended that experienced compliance and legal personnel be involved in all TRO recommendations. These persons should also be available from each reviewing unit to hand carry the case to each succeeding level, for review.

  1. Timeliness

    As a general rule, a request for a TRO should be processed through the agency so that it may be filed no later than 30 days after FDA's most recent evidence that the violation is occurring.

    Also, as a general rule, a request for a preliminary injunction is untimely if the evidence to support it is over 60 days old at the time of filing. The freshness of the evidence is important when the case includes a Motion for Preliminary Injunction, because the government is requesting that the matter be moved ahead of other cases on the court’s calendar because of its urgency.

  2. Seriousness of the Violation

    In addition to considerations of timeliness, if there is a public health threat, that factor is something that should be emphasized. It is very important to remember that we do not need to show potential harm, but if that factor is present, it is very compelling. If the threat is severe enough, the court would consider a TRO for immediate relief.

    The magnitude of the violation is another consideration. If the defendant is a small company with just a few employees and the violations cause little or no public health risk, a court may not grant preliminary relief, but may be receptive to granting a permanent injunction. If the violations are significant and the defendant is a major presence in the industry, the fact that the violations may have far-reaching consequences may be a compelling factor in support of preliminary relief, even if there is no direct evidence of harm.

  3. Adequate Notice

    To avoid the need for updating the evidence in requests for TRO or preliminary injunctions, the agency is committed to prompt review when all of these prerequisites are met. The absence or weakness of a prerequisite may preclude review of the request and the transmission of the case to DOJ until the information is obtained, unless adequate justification for its omission has been provided.

    When initiating requests for injunction with a TRO and in implementing compliance follow-up, all personnel will perform the investigational, analytical, and administrative tasks with a high degree of urgency. Advance notice to all involved units is necessary, so that plans for expedited processing and review may be agreed upon and accomplished.

    A request for a TRO or preliminary injunction must be accompanied by the DD's Affidavit and where appropriate (for example new drug violations), the affidavit of Center personnel attesting to certain facts. Supporting affidavits of experts should be obtained as soon as possible either by the district or the Center.

    Expert witness support is necessary in all cases except when the violations are so gross and apparent that a reasonable judge who is not familiar with the technical or scientific issues in the case would not hesitate to grant the relief without expert testimony. Because expert testimony takes time to obtain, the district or the Center should begin identifying suitable candidates and forwarding the necessary background material to them at the earliest possible time. Please note that any materials provided to experts must be shared with the defendants in discovery. If you have any questions about what should or should not be shared, please contact OCC.

  4. 6-2-7 - Refreshing Evidence - Updating Inspections

    The referral of a Complaint for Injunction to DOJ should follow closely in time the last evidence of violations (inspectional evidence, laboratory analysis, or undercover buy), or the last communication from the proposed defendants which reveals that the violative conduct will continue. This can be controlled to a certain extent by well-timed reinspection, buys, or similar activities.

    Requests for reinspection, undercover buys, or similar activities should be coordinated with the Center and OCC. Assignments for update inspections will be issued directly from the Center after consultation with OCC. The update findings and the district's recommendation based upon this most current evidence should be transmitted concurrently to OCC and the Center.

    6-2-8 - Approval Process for Seizure and Injunction Cases

    See 6-1-5 for the steps to be included for Injunction cases.

    6-2-9 - Responsibilities for Injunction Actions

    1. District Responsibilities:

      Prior to creating a PA work activity in CMS, the compliance officer should consult with the DCB and other district management to obtain support for the proposed action. The district should then create the PA work activity and upload key documents that support the most significant violations, initiate the preliminary assessment call and PA Work Activity in CMS, and upload a document describing summary views expressed during the PA call.

      The district, along with the Center, is responsible for identifying the relevant statutes and regulations they seek to charge and with specificity the relief sought.

      If the participants agree that an injunction may be warranted, the district is responsible for writing and uploading the CIM and supporting documents into CMS. Notify OCC using the address “OC OCC Case.” mailbox in Outlook. The contents of the CIM are described in Exhibit 6-1B.

      When significant changes to the fact pattern that take place after the initial PA call, these changes should be communicated to the lead coordinator as soon as possible. The District lead coordinator is responsible for uploading the new evidence as soon as possible. A new task should be created and participants should be alerted about the changes.

    2. Center Responsibilities:
      1. Appropriate Centers are responsible for providing and obtaining technical/scientific review and support of the case, for assuring that the case meets regulatory policy requirements and for providing a clear indication of scientific support for each charge and each article.
      2. The Center is responsible for preparing for and participating in the PA call, assigning a lead coordinator (who will retain that role throughout the review process), assigning a technical/scientific expert and retaining and obtaining the concurrence of an outside expert when needed, providing views to the district for incorporation into a subsequent summary of the PA call in CMS, and providing input for the CIM to include with specificity those charges that can be supported, those that cannot and the rationale within the time frames outlined above.
      3. The Center, with input from the district and OCC as appropriate, is responsible for determining whether outside experts are necessary to support a case and, if so, for promptly taking steps to secure such support. See Chapter 10 “Expert Support for Cases” for further information, including information on paying for expert support.
      4. In those situations where an expert memorandum or declaration is needed in order to move the action forward, such as in GMP, HACCP, or similar complex cases, a brief memorandum would be provided by the expert. Experts to be used, whether from the Center or outside, should prepare a brief statement that they have read the EIRs, CIM, and analytical worksheets, and that based on this review they can support the following conclusions that are specifically listed. If they cannot support any particular conclusions, those should also be listed. The document should state that they are prepared to testify to the above conclusions (in court and by sworn declaration). The Center lead coordinator should upload the expert’s CV and bibliography into the CMS case file. The concurrent review process encourages increased communication and collaboration and should allow for early identification of this need for a written opinion/commentary, as well as other requirements needed to move a case forward.

        Note: Referral of the case will not be delayed by the Center if an expert has not been identified. However, the Center must be actively pursuing this matter and providing status reports to OCC. The Center will alert OE and OCC promptly if there is difficulty in processing an FDA approval to retain an outside expert. However, OCC may not be able to proceed without the support of expert opinion.

      5. The Center is responsible for reviewing the district’s proposal regarding conduct to be enjoined, ensuring that the proposal is adequate and reasonable.
      6. The Center is responsible for identifying which statutes and regulations they seek to charge, and with specificity the relief sought.
      7. Each Center is responsible for monitoring industry-wide state of compliance to determine whether an enforcement strategy should be developed or revised. This includes a multi-facility firm that may lead to a multi-district injunction action (see exhibit 6-11). Consideration should be based on priorities, prior similar actions, nature and scope of the industry.
    3. OE, Division of Compliance Management and Operation:
      1. Coordinating, reviewing, and consulting with the other participants during the concurrent review process.
      2. Ensuring uniform application of policy and procedures across FDA Centers.
      3. Reviewing final agency action and determining which cases require an update inspection (in conjunction with Center).
      4. Upon approval of an action, DCMO will transmit the final complaint, transmittal letter and ancillary documents electronically to the district where action will be taken, with a copy to the designated OCC contact persons, DOJ/OCL, and FDA’s Office of Public Affairs. DCMO should note in CMS the date that the complaint, transmittal letter and ancillary documents were submitted to the district. The District will upload a PDF version of the signed USA letter and the complaint in CMS. The e-mail will acknowledge that DCMO has received the approval from OCC and should identify the attorneys assigned to the particular case.
    4. Office Of Chief Counsel Responsibilities:

      For injunctions, OCC will participate in concurrent review and provide legal review, prepare pleadings and other legal documents, and provide legal assistance necessary for presentation of the action, including direct assistance to the Office of Consumer Litigation and/or the U.S. Attorney’s Office and the district compliance staff.

    6-2-10 - Cover Letter to DOJ

    The cover letter transmitting the case to the Department of Justice/Office of Consumer Litigation, Civil Division, will be prepared by OCC and will identify the action sought (TRO, preliminary injunction or permanent injunction), briefly summarize the case, highlighting legal, evidentiary, and tactical issues worthy of note including the significance of the evidence.

    6-2-11 - Complaint for Injunction

    OCC will prepare the Complaint for Injunction, in accordance with the requirements of the Federal Rules of Civil Procedure and any particular requirements of the relevant district court.

    The complaint will generally include sections covering jurisdiction, venue, identification of defendants, a statement explaining the nature of the products involved, the purpose of the law that is being violated, a summary of evidence of the violations alleged, a brief reference to prior inspections, prior warnings, and historical non-compliance, and a short-form prayer for relief. See exhibit 6-19.

    6-2-12 - Declarations

    Most jurisdictions will accept declarations in support of a motion for preliminary relief or for a Temporary Restraining Order. If the court requires live testimony in support of a motion for TRO or preliminary injunction, the declaration may be converted to testimony. Please note that declarations are testimony given under oath. Declarants should be prepared to testify in court to all statements made in a declaration.

    NOTE: 28 U.S.C. 1746 provides for the optional use of declarations in lieu of affidavits, thereby avoiding the need for a notary public. This is particularly useful for experts and resident investigators when a notary is unavailable. Declarations filed under 28 U.S.C. 1746 have exactly the same legal weight and significance as affidavits. Where either an affidavit or declaration is used, follow Exhibit 6-20. The 28 U.S.C. 1746 declaration should state, "Pursuant to 28 U.S.C. 1746, I declare under penalty of perjury that the foregoing is true and correct. Executed on (date).”

    If the court requires affidavits from investigators or analysts or others having firsthand knowledge of the facts, they should be furnished by the district or persons performing the work. However, where significant information is discovered in the course of the inspection and is not contained in the FDA 483 or other document, but is within the personal knowledge of the investigator, that observation, discussion of event, or incident should be the subject of a brief declaration by the investigator. Where a separate declaration is used for an investigator, the relevant FDA 483 issued by that investigator should be attached thereto. In some cases, a declaration may also be necessary for the investigator to summarize and explain the significance of the most recent inspectional findings consistent with his or her experience as an FDA investigator.

    The only declarations that will routinely be used in support of injunctions are the declarations of: (1) the district director or designee; (2) an investigator (where necessary to support information in the complaint not contained in the FDA 483 or to summarize the significance of the findings); (3) appropriate Center official (to document such things as the lack of an NDA or the failure to register a product or facility); and (4) experts.

    The declarations should be factual and, except in the case of declarations by experts, not contain conclusions, or opinions. In all cases, each declaration must provide clear, succinct, and strong factual support for the complaint.

    The declarations should set forth the identity of the declarant; his/her position with FDA and his/her duties in that position. If it is an expert's declaration, his/her qualifications to draw conclusions or offer opinions must be summarized at the beginning of the declaration and should be supported with an attached copy of the expert's curriculum vitae.

    Because the granting or denial of a TRO or preliminary injunction may rest upon the sufficiency of the declarations submitted with the complaint, care should be taken to ensure that every statement in the complaint is covered with equal or greater specificity in the declaration. Violative conditions unrelated to the charge should not be included. Unimpressive violative conditions should not be included; however, a number of less impressive violative conditions may often be grouped to become more impressive when their combined effect is to make a potentially hazardous condition.

    NOTE: Listing a series of minor infractions has the effect on a court of minimizing the significance of the case and distracting the focus away from the significant problems.

    The facts in the district director's declaration are derived from a review of documents contained in the district files and the declaration should so state. A district director or investigator may not rely on oral statements made to him or her by other agency personnel. The following specific information should be covered in the declaration:

    1. statement of the position occupied by declarant;
    2. duties of the declarant in that position;
    3. legal status or business of the defendant firms;
    4. address of business;
    5. identity of individual defendants, where they perform their duties, and in at least as much detail as in the complaint, their authority and responsibilities;
    6. a statement that the defendants are doing (or do) interstate business in a product known as (brand name);
    7. the label and labeling of the products (If the labeling is available, it should be attached to the declaration, appropriately identified. If exhibits are not available, relevant portions of the labeling should be quoted when applicable to the charges in the complaint);
    8. if relevant to the charges, establishment inspections performed and the facts revealed thereby;
    9. a statement that samples from recent interstate shipments have been obtained, briefly citing the labeling accompanying the shipments, if pertinent;
    10. sample evidence (include the name of product sampled, and the laboratory findings that confirm the alleged violations);
    11. prior actions such as warnings, notice, seizures, and FDA attempts to obtain correction, broken promises or other evidence of bad faith, such as statements by defendants clearly showing an intent to continue the violations, in detail as pertains to each defendant; and,
    12. a statement that, despite the previous actions, the defendants are still engaged in violative conduct.

    NOTE: All declarations should be prepared in final form, but not be signed, and should be double-spaced. They represent the facts that can be sworn to by an individual. However, changes made in a case during the review process may require changes in the declarations.

    To ensure that the declarations remain accurate, the following will apply:

    1. The declarant will carefully review the final copy before the case is submitted. The only signed version should be the final version after all changes have been agreed upon, reviewed, and cleared by the signer.
    2. If substantive changes are made in the declaration, the reviewing office proposing the change will check with the district to ensure the individual can attest to the truthfulness and accuracy of the added material. OCC will be responsible for incorporating all approved changes into the final.
    3. In no case will a declaration be modified without the knowledge and express consent of the declarant.

    6-2-13 - Consent Decree

    OCC will prepare the proposed consent decree, using the section in the district’s CIM titled “Violations,” and additional information provided by the Center.

    The District and the Center are jointly responsible for providing OCC with the information necessary to support the specific substantive relief sought. See Exhibit 6-18

    In drafting a consent decree, OCC will seek Center approval on matters germane to its original review, including reconditioning or reprocessing plans, CGMP requirements, reviews of the corrective actions of defendants, recalls, cessation of product manufacturing or distribution operations, and measures that could affect availability of medically necessary products. OCC will seek the district’s approval on matters requiring district follow-up activities, such as reinspection frequency and rates, reviews of defendant’s corrective actions if any were requested by Center, and witnessing destruction and disposition of goods.

    Also, during litigation, representatives of those offices with a direct interest in the case will keep each other informed of developments, including changes proposed by DOJ attorneys, to ensure that a consent decree is filed that are acceptable to the agency (district, Center, and OCC).

    FDA should not seek relief if it cannot be obtained (e.g., do not propose to allow reconditioning of a product if it cannot be accomplished). Also, if the relief provides for the company to obtain a consultant, do not require, as part of the relief that FDA approve of the consultant.

    6-2-14 - Costs of Supervision

    All injunction actions should provide for the payment of costs incurred to ensure that the defendants are brought into, and remain in compliance with terms of, the court's order before they can resume operations subject to the order.

    The following charges apply to all injunctions:

    Investigation time: 266% of GS-11/4 hourly rate

    Analytical time: 266% of GS-12/4 hourly rate

    Per diem actually paid to an FDA employee will be paid at the current existing rates expressed in GSA's Federal Travel Directory.

    Miscellaneous expenses: actual cost

    The minimum charge for services shall be not less than the charge for one hour. Additional charges shall be in multiples of one hour, disregarding fractions of less than 1/2 hour, as follows:

    1 hour through 1 hour, 29 minutes - charge 1 hour

    1-1/2 hours through 2 hours, 29 minutes - charge 2 hours

    Consult with OCC before notifying the firm by letter that it may resume operation (see Exhibit 6-12) and before sending an initial bill setting forth the charges for all work performed to get the firm in compliance (see Exhibit 6-22). Do not use a letter to notify either the firm or the U.S. Attorney that costs have been paid, because this may result in the injunction being inadvertently canceled.

    6-2-15 - Compliance Follow-Up

    Once the injunction has been granted, the Court and the public rely on FDA to conscientiously monitor the defendants' compliance and to advise the Court on compliance with the terms of the injunction.

    It is the responsibility of the district to ensure that prompt attention is given to the following:

    1. Consult with OCC as to service of copies of the court's decree.
    2. Determine the firm's plans to bring the operation into compliance and, where applicable, the plans for destruction, reconditioning, or recall of material on hand and finished goods in the market place.
    3. Where the injunction contains a provision for the firm to designate an expert to supervise compliance with the terms of the decree, it should specify that the expert must certify in writing to FDA that the terms of the decree have been complied with before FDA makes any inspection, and that the firm must submit a written list of corrections to FDA.
    4. Find out whether the firm has hired a qualified expert, and determine his/her qualifications. FDA does not approve or disapprove of experts selected by defendants when defendants are required by a consent decree to retain expert consultants. However, FDA may elect not to accept a consultant’s report of findings. FDA acceptance of the consultant's findings may include consideration of such factors as the adequacy, completeness, or accuracy of the filed report, if an obvious conflict of interest is uncovered, or if the consultant’s competency does not meet a regulatory standard (for example, as required in the drug CGMP regulations at 21 CFR 211.22). The district should share the follow up findings with the Center either by email or telephone.
    5. Monitor status of the accomplishment of the above. Promptly advise OCC and the appropriate Center of any problems regarding non-compliance with the decree. Maintain close contact, including visits, as necessary, to ensure that the firm is brought into compliance before operations subject to the injunction are resumed.

    NOTE: Inspections made under an injunction are performed under the authority of the appropriate Act and the decree entered by the court. When visiting the firm, provide a copy of the decree and FDA 482 to managerial personnel and document that you have done so. This will facilitate any contempt action that may be necessary.

    Following determination by the district that the defendants appear to be in compliance with the requirements of the "unless and until" provisions of the decree, the defendants should be so notified in writing and advised that such determination does not, however, relieve them of their responsibility for compliance with the Act or other provisions of the decree that continue in effect (see Exhibit 6-12 Model Letter Acknowledging Compliance). Consult with OCC before notifying the firm by letter (Exhibit 6-12) that it may resume operations and before sending an initial bill setting forth the charges for all work performed to get the firm in compliance (Exhibit 6-22).

    NOTE: If a copy of the above letter is furnished to the U.S. Attorney, it may inadvertently trigger a dismissal action unless the U.S. Attorney is also reminded that there are other provisions of the injunction that remain in effect.

    If the district's follow-up discloses that the firm has met the provisions of the decree and notice has issued, the district will schedule a follow-up inspection to be performed in 3 to 4 months and quarterly thereafter until the firm maintains a continuous state of compliance for one year. The firm shall be inspected at least annually thereafter. Deviation from this schedule is appropriate in those instances where plant operations are on a seasonal basis. In that event, the firm shall be scheduled and inspected at the beginning of the next operating season.

    Should any reinspection or analysis of samples disclose that the defendants are not meeting the terms of the decree, a variety of regulatory actions are available to FDA, including:

    1. Reinstatement of Decree

      Motion to petition the Court to implement the shut down provisions of the decree, based on the fact that defendants regressed from an in-compliance state (as certified in formal notice) to an out-of-compliance state. The effect of this action is to again close the firm until corrections have been made and verified. If the decree allows for a recall, upon request by FDA, this, too, may be considered.

    2. Seizure
    3. Civil Contempt

      A civil contempt is a forward looking action to force compliance, requesting the court to impose a penalty upon the defendant for continued noncompliance. The penalty may be monetary or confinement of individual defendants for each day or for each violative act until the terms of the decree are met.

    4. Criminal Contempt

      A criminal contempt action is not to coerce compliance, but to punish prior behavior. The penalty does not depend upon future actions.

    5. Prosecution
    6. Civil money penalties (for example, for medical devices or tobacco products)
    7. Administrative sanctions such as Withdrawal of Applications.

    NOTE: The foregoing regulatory actions may be applied individually, sequentially, or concurrently. The consideration of any regulatory action should be discussed with the Center, DCMO, and OCC.

    Recommendations for any action taken as the result of a violation of a decree shall be processed with the same urgency as the original injunction, and in accordance with the procedures in this chapter. The district compliance office will prepare a recommendation. For criminal contempt, see the RPM section "Contempt of Court; Violation of Probation". For prosecution see the RPM section, "Criminal Prosecution After 305 Notice". Should contempt be the action of choice, the district will also prepare a Petition for Order to Show Cause why the defendants should not be held in contempt. See Exhibits 6-23 and 6-24.

    Change in ownership or identity of defendant firm should be noted. In the case of a change in ownership or corporate identity of the firm, report detailed facts on the changes to the Center and the OCC for a determination whether the new ownership or corporate entity are covered by the injunction. Rule 65(e), Federal Rules of Civil Procedure, discusses persons covered by injunctions.

    If a firm under injunction goes out of business, take the following steps:

    1. Maintain the file as an open injunction for one year.
    2. Check the status of the firm at the end of six months and one year after being reported out of business.
    3. Make an effort to determine whether the firm has moved to another location and another district should be notified of the status of the firm. Notify any such district about the injunction.
    4. If the injunction is against an individual as well as a firm, determine the individual's present occupation, and whether or not it is similar to the type of business for which he/she was enjoined. If so, notify the Center and OCC.
    5. If the firm remains out of business after one year, notify OCC and the appropriate Center of your intention to close the file in 60 days unless either component has further information which requires consideration.
    6. After the 60 day waiting period, if no further information is received, and the injunction was a preliminary one, notify the U.S. Attorney in writing that the firm has ceased operations and the government recommends closing the injunction file.

    6-2-16 - Vacating Injunctions

    FDA does not ordinarily initiate requests to vacate injunctions whether issued by consent decrees or court orders. Nor will the agency join with a defendant in filing a motion to request such relief. However, if all of the following apply, FDA may agree to not oppose such a motion: (1) the agency has recent evidence (e.g., within the last 6-8 months) that the defendant is in compliance with the Act, applicable regulations, and the decree or order; (2) the defendant has remained in continuous compliance with the Act, applicable regulations, and the decree or order for the life of the sunset provision (virtually always five years); and (3) the defendant has given FDA an opportunity to consider whether or not to object to the motion. A long violative history or lack of cooperation by the defendant will also affect FDA’s response to a motion seeking to have an injunction vacated.

    If a defendant contacts the appropriate district(s) to discuss the possibility of vacating an injunction, the defendant should be instructed to prepare a written request specifically describing the evidence to show how it has met each of the foregoing criteria. The district and Center should not discuss their views about vacating a decree with the defendants or their counsel. That request should be forwarded to OCC (Deputy Chief Counsel and Associate Deputy Chief Counsel for Litigation), the relevant Center(s), and OE, together with the district's views, which should include a description of the results of the most recent inspection and the defendant's overall inspection history since the injunction was entered. If OCC, the district, the Center, and OE do not object to vacating the injunction, OCC will inform the defendant's counsel that FDA will not oppose a motion requesting such relief.

    Thereafter, the defendant's counsel should prepare, in draft, a short motion briefly describing the sunset provision, the defendant's compliance therewith, and the fact that FDA has read the motion and does not object to the relief sought. If OCC agrees with the motion, it will take steps to contact the Department of Justice so that the motion may be filed without opposition from the United States.

    6-2-17 - Issuing Press Releases

    The recommendation to issue a press release is made jointly by the OCC attorney assigned to the case, the ORA case officers (the district compliance officer or OE), and the Center’s compliance office. The decision to issue a press release is made by FDA’s Office of Public Affairs in accordance with the Transparency Initiative. The roles and responsibilities of these offices in making these decisions, and in drafting, clearing, and issuing press releases are described in “Procedures for Issuing Press Releases on Enforcement Activities (Seizures & Injunctions).” (See Exhibit 6-10) Follow these procedures and the accompanying models for drafting press releases concerning seizures and injunction actions. Upload the press release in CMS. See 6-1-13 and Exhibit 6-10 Issuing Press Releases

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