FDA’s new draft guidance on “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection” has drawn some industry concern regarding the degree of subjectivity it affords investigators in determining when the lines have been crossed.
In its submitted comments on the draft and in discussions at recent meetings, industry has been expressing support for the agency’s effort to strengthen its ability to conduct meaningful inspections as provided for by Section 707 of the FDA Safety and Innovation Act. FDASIA called for FDA to issue a guidance explaining how Section 707 would be interpreted within a year after the act’s passage in mid-2012.
However, industry commenters have expressed concern with the amount of latitude the draft guidance gives to individual investigators in drawing the compliance boundaries, in view of their varying skill levels and temperaments and the varying circumstances of the inspection situations involved.
Reflecting the title, the nine-page draft guidance contains separate sections on delaying, denying, limiting, and refusing inspections, respectively, and includes examples of situations and behaviors that have resulted in those determinations, culled from investigator experience in the US and abroad.
The guidance allows an investigator to deem a drug adulterated if facility personnel impede an investigation, including not allowing photographs to be taken during an inspection. Inspection photography is a perennial issue in the industry/regulator dialogue, which the new draft guidance has reinvigorated.
Recent Inspections Demonstrate Need for Guidance
Recent warning letters to firms in India and China have brought into high relief the range of tactics that can be employed to stymie FDA inspections. The tactics, in turn, are generally linked in the letters to data integrity lapses, which the tactics are intended to cover up (IPQ, August 22, 2013).
[CLICK HERE for the complete story. Along with further analysis of the industry comments on the guidance, the story includes insights from an FDA compliance official provided at a recent conference and a review of the discussions that followed. Nonsubscribers can purchase the story for $195 by contacting Jonathan Trethowan (Jonathan@ipq.org). For subscription/license information, click here.]
See related IPQ stories:
FDA Data Integrity Concerns Continue in India as Three More Firms Draw GMP Warning Letters
FDA’s Center for Drugs Redoubles Effort to Achieve 21st Century Quality Vision and Foster Continuous Process Improvement
FDA Seeking Industry Input on Quality Metrics to Help Rationalize Its Review and Inspection System
FDASIA Title VII Implementation Priorities and Action Plans Taking Shape
