FDA’s GUIDANCE FOR INDUSTRY PROVIDES CIRCUMSTANCES THAT CONSTITUTE DELAYING, DENYING, LIMITING OR REFUSING A DRUG INSPECTION

LEARN OF FDA’s CURRENT THINKING REGARDING AUDITING ISSUES

The FDA recently released a new DRAFT Guidance for Industry on July 12, 2013 that is entitled “Circumstances that Constitute Delaying, Denying, Limiting or Refusing a Drug Inspection”.  The Draft Guidance for Industry uses examples that illustrate the most common situations that the FDA has encountered and provides very informative reading.  This document which discusses delays of inspections illustrates some of the frustrations that the FDA encounters following efforts to schedule pre-announced inspections, delays during an inspection, denial of inspection, limiting of inspection, and refusal to permit entry.

Please visit: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM360484.pdf to learn more about this informative DRAFT.