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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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      10-2-1 - Purpose
      10-2-2 - Background
      10-2-3 - Policy
      10-2-4 - Procedures


  10-2-1 - Purpose

This section defines "prior notice" and establishes uniform criteria to determine if adequate prior notice has been provided.

  10-2-2 - Background

Except in a few specifically defined areas, the Food and Drug Administration (FDA) has no legal obligation to warn firms or individuals that they, their practices, or their products are in violation of the law prior to taking formal enforcement action. However, a basic principle of FDA's enforcement policy is the belief that the majority of persons will voluntarily comply with the law when given information as to what is required, what violations appear to exist, and, in the case of violations of regulatory significance, that failure to comply may result in the initiation of enforcement action.

  10-2-3 - Policy

When it is consistent with the public protection responsibilities of the agency and if a violative situation does not present a danger to health or does not constitute intentional, gross or flagrant violations, it is FDA's policy to afford individuals and firms an opportunity to voluntarily take appropriate and prompt corrective action prior to the initiation of enforcement action. If voluntary correction is not achieved, documentation that adequate prior notice was provided strengthens the agency's position in enforcement actions by establishing that responsible individuals continued violating the law despite having been warned by the agency.

The following factors should be considered in evaluating the adequacy of prior notice (prior warning):

  1. The conduct, condition, practice, or product violates the laws enforced by FDA.
  2. The notice (warning) adequately identified the violative conduct, condition, practice or product. (Note: Similar violations do not need separate prior notices, for example, separate prior notices are not necessary for each unapproved new drug shipped.)
  3. Notice (warning) was provided to the firm and the most responsible individuals.
  4. The firm was afforded a reasonable amount of time to implement corrections. Corrections may include halting shipments, recalling product in violation, or changing procedures and controls.
  5. Consider if situations have occurred that may affect the adequacy of prior notice, such as a change in ownership or responsible management. For example, consider what is known by the new management, and if the "firm" received notice.

Note: Prior Notice may be provided orally or in writing. Where there is no dispute as to what is required to comply with the law, adequate notice may well be the Investigator's discussion of objectionable conditions with responsible management at the conclusion of the inspection. If, however, the violative conduct involves a controversial area, an area in which policy is still emerging, or one that has not been pervasively regulated in the past, written notice (usually in the form of a Warning Letter) may be required prior to the initiation of enforcement action.

Consideration of these factors will facilitate meeting the prior notice requirements for civil and certain criminal actions.

  10-2-4 - Procedures

Warning Letters are the principal means by which the agency provides prior notice of violations and of achieving voluntary compliance. See RPM Chapter 4, Advisory Actions. However, Prior Notice may be provided by means of a civil suit, administrative action, or other less formal ways, including the following:

  1. Enforcement action or notification by State, municipal or other Federal agencies involving the same or similar violations.
  2. Issuance of the FDA-483, List of Observations, at the conclusion of an inspection. Issuance of a copy of the FDA-483 to a firm's most responsible person(s) must follow guidance in Field Management Directive 120.
  3. Discussion with management by an FDA investigator, documented in the EIR.
  4. Recall Classification Notification Letters.
  5. Properly documented meetings or telephone conversations between agency officials and a firm's top management (see section on Regulatory Meetings in this chapter).
  6. Properly documented advisory communications by FDA Center personnel concerning critical scientific issues.

Note: For further information related to "properly documented" telephone conversations and meetings, see Staff Manual Guide, External Relations, Guide 2126.2, Memoranda of Telephone Conversations and Meetings with Non-FDA Persons, on the OIRM Intranet site.