Inspections, Compliance, Enforcement, and Criminal Investigations


6-3-1 - Purpose
6-3-2 - Inspection Warrants
6-3-3 - Responsibilities


6-3-1 - Purpose

To provide procedures for obtaining inspection warrants. Procedures for Search Warrants are discussed in a separate section.

6-3-2 - Inspection Warrants

The Food and Drug Administration (FDA) does not routinely request inspection warrants in order to conduct investigations or inspections of regulated industry. However, warrants have been used effectively to gather information that has been refused improperly. Inspection warrants should be recommended as soon as possible after a refusal is encountered. A past refusal is not a prerequisite to seeking an inspection warrant. (NOTE: "Inspection warrant" and "administrative inspection warrant" have the same meaning.)

Inspection warrants may be sought when inspection has been refused completely or when refusals have been encountered in limited areas; for example, when photography or sample collection has been refused.

There are situations where FDA will seek a preemptive inspection warrant; for example, when there is a history of prior refusals from a firm and FDA anticipates a current refusal to inspect. Also, FDA may seek a preemptive inspection warrant prior to initiating a scheduled inspection when there is a documented corporate policy mandating refusal in a particular area (such as photography, sample collection, or copying of records), or there is good reason to believe that required information will be refused and that information will then be destroyed before an inspection warrant can be obtained.

Before seeking an inspection warrant, the agency needs to ensure that:

  1. FDA is entitled by statute or regulation to inspect the facility and to have access to the information which has been refused; and
  2. there is a compelling FDA need for that information, and
  3. the firm/individuals have refused to allow inspection or access to information in spite of a clear demonstration or explanation of appropriate statutory authority.

6-3-3 - Responsibilities

Recommendations for inspection warrants are given high priority and handled expeditiously by all offices involved in their review. Under ordinary circumstances, the Office of the Chief Counsel (OCC) is not involved with the procedures for determining the need for an inspection warrant until the responsible center and the Division of Compliance Management and Operations (DCMO) determine that the application should proceed.

  1. District
    1. Preliminary Steps

When the criteria for requesting an inspection warrant are not clear, the district should consult with DCMO, prior to submitting a request for an inspection warrant. DCMO is located at 10903 New Hampshire Avenue, Silver Spring, MD, 20993. Telephone 301-796-8200; FAX 301-847-8635.

When the district decides to recommend an inspection warrant, the district should contact DCMO by telephone, provide advance notice, ascertain the DCMO contact person, obtain any additional guidance, and upload the documents listed below into CMS (Compliance Management System). The district should transfer the case to DCMO by changing the current owner to DCMO pursuant to CMS procedures. CMS will automatically send an e-mail to the person in DCMO designated to receive notification when actions have been submitted to that office. Prior to changing ownership for submission of the action, the district should identify all potential or suspect adulteration and/or misbranding charges cited in the subject action under the Act/CFR tab in CMS.

    1. What to Include
      1. Cover Memorandum. The cover memorandum should summarize the circumstance(s) justifying the need for an inspection warrant. The memo must cover the following elements:
        • The statutory or regulatory authority to conduct the inspection or to obtain the information.
        • Why there is a compelling need to conduct the inspection or obtain the information
        • A clear description of the refusals encountered or, if refusals are anticipated, the reasons why a refusal is expected. Include a description of the efforts to explain our statutory authority and the firm’s continued refusal in spite of this explanation
        • Each type of information sought and refused, and an explanation why the information can not be obtained through other means
        • The status of the inspection (ongoing, terminated, or anticipated)
        • The reason for the inspection; prior warrants obtained; and, if applicable, violations observed
        • Any situation that may result in a refusal or delay of an inspection conducted under a warrant.
        • Any other pertinent information, for example, the location is a personal residence or the district anticipates resistance during execution of the inspection warrant, in which case a strategy for dealing with the anticipated resistance should be outlined
        • Factors that are known to involve danger to the public, the inspecting persons, or others, (for example, weapons, guard dogs, or hazardous chemicals).
      2. Draft Application for Inspection Warrant. The application for inspection warrant forms the basis for the agency's request to the Court. If there are multiple locations under the control of the same firm, prepare individual applications and warrants to cover each location. The application must include the following elements:
        • The correct address of the premises to be inspected. If the inspection is to extend to a vehicle, a precise description of the vehicle, including the color, make, model, and license number of the vehicle.
        • The statutory authority to inspect the establishment and the items sought.
        • Any violations observed during the course of the current investigation or the most recent inspection, specifically citing the language and section of the Act being violated. Although it is not required that a violation has occurred in order to obtain approval of an inspection warrant, the Department of Justice (DOJ) has asked that such information be included in the Application, when available.
        • A detailed description of any relevant refusals, including, for example, and not limited to: the individuals making the refusals, their titles, the dates of the refusals, any additional responsible individuals involved in or consulted about the refusals, the reasons given, any written corporate policy regarding the refusal, the names of investigators to whom the refusals were addressed.
        • A detailed description of the reason for our inspection, or investigation during which the refusal was made, emphasizing that inspection was made at a reasonable time, in a reasonable manner, and describing any agency directives or programs which authorized the inspection and its scheduling.
        • A description of the items that will be sought during the execution of the warrant.
        • A description of the manner in which the requested inspection will be conducted pursuant to the warrant, such as the use of one or more investigators or U.S. Marshals to accompany the requesting investigator on the inspection, sample collection, and photography, and, where appropriate, copying of records.
      3. A Draft Warrant. Include a draft copy of the inspection warrant.
      4. Other Information and Documentation. Include any pertinent supporting documentation or background information.

        *NOTE: Recent models of Warrant Applications and Warrants may be available from ORA/DCMO, telephone 301-796-8200.

    2. Processing

      The district should transfer the case to DCMO by changing the current owner to DCMO pursuant to CMS procedures. CMS will automatically send an e-mail to the person in DCMO designated to receive notification when actions have been submitted to that office. Prior to changing ownership for submission of the action, the district should identify all adulteration and/or misbranding charges cited in the subject action under the Act/CFR tab in CMS.

      The district will promptly alert DCMO of copies of approved, filed warrants uploaded in CMS and keep DCMO informed of the progress of the inspection under the warrant.

      DOJ prefers, and FDA encourages, that U.S. Marshals accompany FDA investigators when warrants are executed. If this presents a problem for the district, DCMO should be notified immediately. The recommending district should anticipate and set forth in the cover memorandum any situation that may result in a refusal or delay of an inspection conducted under a warrant. Whenever possible, an agency decision and implementation strategy regarding anticipated resistance, possible arrests, or use of force during execution of the inspection warrant should be considered and made prior to execution of the warrant.

      If problems are encountered during the application for or execution of the warrant, DCMO should be contacted immediately. If there is a legal issue, contact Office of Chief Counsel and DCMO immediately. A return (a statement indicating completion of the inspection conducted under warrant) must be made to the Court within 10 days of completion of the inspection. The return is a separate document prepared as part of the draft warrant application. It is simply a statement from the Investigator who was authorized to conduct the inspection that the inspection was made on a certain date(s). The document is filled in with the date of inspection, signed by the Investigator, and returned to the Court. A copy of the return should also be uploaded into CMS and a hardcopy should be forwarded to OCC.

  1. Division of Compliance Management and Operations

    When a recommendation for an inspection warrant is transferred, DCMO maintains ownership but will send a task in CMS to the responsible centers for concurrent review. The centers and DCMO will review the recommendation and proposed documents to assess the need for the action, the agency's statutory authority, completeness, accuracy, format, and conformance with current DOJ requirements. The center indicates the completion of their review by uploading associated documents into CMS and closing the “task” pursuant to procedures in CMS. DCMO will provide hardcopies of the revised documents to OCC. Throughout the process, DCMO will monitor and coordinate the concurrent review and processing of the inspection warrant with the recommending district, center, and subsequently with OCC, and DOJ. If a warrant application is not approved, a written explanation of the decision will be uploaded into CMS and DCMO will indicate “Non-Concur” in the internal decision field, adding the completed date and changing the current owner to the District. CMS will automatically send an e-mail to the person in the district designated to receive notification when ownership of a case has changed to that office. The District should close out the case pursuant to CMS procedures.

    If through concurrent review by the center and DCMO, a warrant application package is approved, DCMO will revise the documents as needed, upload them into CMS and indicate “Concur” in the internal decision field, add the completed date and update the FDA Final Decision to Approved. DCMO will forward hardcopies of the revised documents to the Deputy Chief Counsel for Litigation, OCC. After review and approval of the warrant application package by OCC, DCMO will prepare a transmittal memorandum addressed to DOJ from the Director, Office of Enforcement (OE) and upload this document into CMS.

    DCMO transmits the warrant package approved by the Director, OE to DOJ by fax, electronically, courier, or overnight delivery and coordinates final revision and processing of the warrant application package with DOJ and OCC. Following DOJ review, DCMO uploads into CMS the DOJ approved (or denied) warrant application package, including any necessary guidance or instructions for the application and execution of the warrant. Action ownership will end with DCMO.

    DCMO notifies the Associate Commissioner for Regulatory Affairs (ACRA) and designated contacts in the Office of External Affairs of the strategy and impending action immediately after forwarding a warrant application package to the district for filing with the court. DCMO uploads into CMS the files of all warrant recommendations.

  2. Center

    The responsible center promptly reviews all warrant application documents forwarded to it by DCMO, ensuring center support (or providing reasons for disapproval) and the accuracy of statutory references, with special emphasis on the authority for access to those items sought to be inspected. Where possible, revisions to documents should be highlighted and uploaded into CMS. Disapprovals are documented in writing and uploaded into CMS over the signature of the Director, Office of Compliance, or his/her designee.

  3. Office of Chief Counsel

    Office of Chief Counsel promptly reviews the warrant and application package for legal sufficiency. Revisions are forwarded to DCMO for typing and transmittal to DOJ. Any disapprovals should be documented in writing and DCMO should upload them into CMS.


Page Last Updated: 06/19/2015
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