New FDA Inspection Guidance gives the Agency more Power

The U.S.  Food and Drug Administration (FDA) is obliged to carry out inspections of facilities at reasonable times, within reasonable limits and in a reasonable manner. However, sometimes the FDA is not able to perform their tasks. Some companies delay or deny an inspection or even refuse the inspector to enter.

Now, the FDA has published the final Guidance for Industry: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection. Based on the title, the document is divided into four sections:

  • Delay of Inspection (not agreeing to an inspection start date or unreasonably delaying),
  • Denial of Inspection (active behaviour by the owner or an operator to prevent an authorized representative of FDA from conducting an inspection or to prevent FDA from completing an inspection),
  • Limiting of Inspection (for example denial to disclose or permit observation of the manufacturing processes or unreasonably restricts entry to a particular facility without adequate justification),
  • Refusal to Permit Entry (includes also passive behaviour and non-action preventing the FDA representative to enter or inspect the facility.

In the case a drug that "has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection", it will be considered adulterated. This would give the FDA much more power when dealing with uncooperative companies. This would be also applicable during an inspection; if an inspector asks for records that FDA has the right to review during a reasonable period of time and the records are not provided, the drug can be considered adulterated!

The draft Guidance was published in July 2013. The final version contains a few examples for potentially reasonable explanations that industry can have to avoid trouble:

  • "A facility does not provide the FDA investigator access to aseptic processing areas until the investigator accommodates the facility's documented gowning procedures.
  • The FDA investigator requests translation of the records into English, and the translation is not readily available.
  • The records requested are not available at that time because they are being used for a manufacturing operation that is in progress.
  • The volume of the records requested is sufficiently large as to require reasonable time to compile.
  • At the beginning of an unannounced inspection, appropriate personnel are not immediately available to accurately answer the FDA investigator's questions.
  • The FDA investigator arrives for an unannounced inspection, but the facility is closed due to scheduled maintenance.
  • Training specified by the Occupational Safety and Health Administration is required before an individual may enter a particular area of the facility, and the FDA investigator has not completed such training.
  • The chemical properties of products manufactured at the facility are such that taking photographs would adversely affect product quality."

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