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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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4-3 - USE OF STATE EVIDENCE FOR FDA WARNING LETTERS AND UNTITLED LETTERS

Evidence obtained by state personnel may be sufficient to support the issuance of Warning Letters and Untitled Letters if the standards and criteria used by state personnel provide reliable support for regulatory actions the agency may take consistent with the agency’s guidance on regulatory actions and laboratory procedures.

  1. If state evidence involves inspectional observations made solely by state personnel, factors that indicate that the standards and criteria used are reliable for these purposes include, but are not limited to, the following:
    1. The state inspector made the inspectional observations during an inspection conducted pursuant to an agency contract inspection program or a joint inspection program in which FDA participates; or
    2. The state inspector made the inspectional observations after receiving training in relevant law and any specific requirements applicable to the inspection and the establishment or commodity being inspected; or
    3. The state inspector received an "acceptable" rating if audited by a qualified FDA or state auditor under FMD 76, "State Contracts – Evaluation of Inspectional Performance" (or other applicable audit program); or
    4. The state inspector detected and documented the observations in the manner set forth in FDA’s inspectional procedures, such as the Investigations Operations Manual, guides to inspections, or comparable inspectional approaches.
  2. If state evidence involves laboratory data, factors that indicate that the laboratory data and the methods and procedures used to collect and analyze the sample are valid and reliable include the following:
    1. The procedures involved in the sample collection have been analyzed and found to be reliable in that the sample was collected, handled, and analyzed using procedures that assure sample integrity and chain of custody and a sample size and test method the Director, Division of Field Science (DFS), HFC-141, determines to be appropriate; or
    2. The Director, DFS, designates that the laboratory data from state facilities meet the criteria and standards appropriate for compliance decision-making; or
    3. The Director, DFS, has reviewed and endorsed the state laboratory findings through an evaluation of the laboratory operations, methods, sampling, and evidence documentation.
  3. Except for state inspections of retailers to determine compliance with the provisions of the Family Smoking and Tobacco Control Act and its implementing regulations, the district office must review and endorse the state evidence as meeting the criteria for the issuance of a Warning Letter or Untitled Letter in accordance with district procedures and agency compliance policy.  Warning Letters and Untitled Letters relating exclusively to state inspections of retailers to determine compliance with the provisions of the Family Smoking and Tobacco Control Act and its implementing regulations will be drafted by the Center for Tobacco Products based on sufficient evidence collected and documented by state personnel.
  4. The FDA product center with primary jurisdiction over the establishment or commodities inspected and the Office of Chief Counsel concurs with the use of the evidence obtained by state personnel.
  5. This section is not applicable where a proposal for a Warning Letter or Untitled Letter is based on FDA-developed evidence to demonstrate the current condition of the commodity or establishment, and evidence obtained by state personnel is used to solely demonstrate prior compliance history.