The FDA issued draft guidance July 12, 2013 for comment.  The comment period closed in September and FDA is currently reviewing industry comments prior to publishing a final rule.

This guidance attempts to clarify unreasonable conditions when an owner, operator or agent causes the delay of an inspection this may cause the drug to be adulterated under section 501(j) of the FD&C Act.

Section III B addresses delays during inspection as:

Minor delays that result from good faith efforts by the facility to comply with FDA requests generally would not be considered unreasonable. Examples of delays during an inspection that may cause drugs to be adulterated under section 501(j) of the FD&C Act include, but are not limited to:

  • A facility does not allow the FDA investigator access to an area of the facility until a specific future date or time even though the area is operational and is an area of the inspection site that FDA has authority to inspect. 
  • A facility leaves the FDA investigator in a conference room without access to necessary documentation or responsible individuals for an unreasonable period of time that interferes with the investigator’s ability to complete the inspection.

Section III C address delays in producing requested records, section IV, V, and VI address denial, limitation of inspection, and refusal to permit entry or inspection.

Some of the guidance is very straight forward i.e., A facility refuses to allow the FDA investigator to review the facility’s shipping records that FDA has authority to inspect. However, other guidance is not so straight forward and may be subject to inspector interpretation.  For example – what is an unreasonable time to leave the inspector in the conference room?  What is a reasonable time frame to produce requested records? What is adequate justification for delays?

As of October 6, 2013, twelve industry groups have provided comments.  Their comments are located here.  These comments address industry concerns associated with the guidance and seeks clarification on what is reasonable and unreasonable , limitations on photographs, rescheduling inspections or start times etc.

The QMN Weekly Bulletin (Nov 2013) provides some additional guidance on this topic, at least from the FDA Baltimore district office. Their interpertation of a reasonable time period is 24 to 36 hours. However, if there are issues in providing requested records it is important to let the FDA investigator know earlier rather than later. FDA Investigator Lori Lawless stated, “If after 36 hours there are still no records than that is a problem.”

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