Inspections, Compliance, Enforcement, and Criminal Investigations
6-2 - INJUNCTIONS
6-2 - INJUNCTIONS
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
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.
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.”
- 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.
- 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.
- 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.
- 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:
- 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
- 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
- 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.
- 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.
- 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.
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.
- 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:
- The individuals with authority to prevent or correct violations have been given appropriate notice of the general conditions that are violative.
- There is sufficient information to conclude that proper action to correct the violations has not been taken or will not be taken promptly.
- 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.
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.
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.
- 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.
- 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.
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.
See 6-1-5 for the steps to be included for Injunction cases.
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.
- 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.
- 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.
- 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.
- 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.
- The Center is responsible for reviewing the district’s proposal regarding conduct to be enjoined, ensuring that the proposal is adequate and reasonable.
- The Center is responsible for identifying which statutes and regulations they seek to charge, and with specificity the relief sought.
- 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.
- Coordinating, reviewing, and consulting with the other participants during the concurrent review process.
- Ensuring uniform application of policy and procedures across FDA Centers.
- Reviewing final agency action and determining which cases require an update inspection (in conjunction with Center).
- 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.
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).”
- statement of the position occupied by declarant;
- duties of the declarant in that position;
- legal status or business of the defendant firms;
- address of business;
- identity of individual defendants, where they perform their duties, and in at least as much detail as in the complaint, their authority and responsibilities;
- a statement that the defendants are doing (or do) interstate business in a product known as (brand name);
- 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);
- if relevant to the charges, establishment inspections performed and the facts revealed thereby;
- a statement that samples from recent interstate shipments have been obtained, briefly citing the labeling accompanying the shipments, if pertinent;
- sample evidence (include the name of product sampled, and the laboratory findings that confirm the alleged violations);
- 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,
- a statement that, despite the previous actions, the defendants are still engaged in violative conduct.
To ensure that the declarations remain accurate, the following will apply:
- 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.
- 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.
- In no case will a declaration be modified without the knowledge and express consent of the declarant.
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.
It is the responsibility of the district to ensure that prompt attention is given to the following:
- Consult with OCC as to service of copies of the court's decree.
- 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.
- 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.
- 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.
- 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.
1. Reinstatement of Decree
4. Criminal Contempt
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.
- Maintain the file as an open injunction for one year.
- Check the status of the firm at the end of six months and one year after being reported out of business.
- 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.
- 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.
- 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.
- 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.
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.