Regarding your post about a DMF being referenced in an IND triggering an FDA inspection, generally FDA does not conduct inspections on this basis. However, when I was in FDA occasionally reviewers would request a brief inspection covering an IND (particularly for Phase 3) when the referenced company was totally unknown to FDA. This may be the case for a company establishing a new manufacturing site. Companies cannot request inspections. Likely, the first FDA inspection will occur as a pre-approval inspection during review of an NDA.
However, there is a program for Pre-Operational Reviews of Manufacturing Facilities which is outlined in Field Management Directive (FMD) # 135. FMD 135 which has existed for many years with the latest version on the FDA website dated Nov. 2009, instructs companies to contact the FDA District Office where the facility is located. The 2009 FMD version does not reflect the current FDA Field organization, so the proper contact could be different, but the local District Office is a good start.
Pre-operational reviews are not inspections, but are intended to provide guidance during the planning and construction of new facilities. The FMD outlines 4 types of reviews (design, pre-construction, pre-qualification, and pre-production) depending on the state of site readiness.
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Peter Smith
Principal
Smith GMP Consulting
Narragansett, Rhode Island
USA
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Original Message:
Sent: 16-Feb-2024 07:58
From: Glen Park
Subject: Triggering FDA inspection for API manufacturer
For a DMF referenced in an IND, I don't think it is possible to trigger an FDA inspection. FDA inspections only occur for NDA/BLA applications. If you are looking for a GMP certificate for a US manufacturer, good luck. You could get an inspection by an EU Qualified Person. If the company is registered with FDA and has an inspection record that information is available.
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Glen Park PharmD
Consultant
Burien WA
United States
Original Message:
Sent: 14-Feb-2024 01:42
From: Anonymous Member
Subject: Triggering FDA inspection for API manufacturer
This message was posted by a user wishing to remain anonymous
Dear community,
A company is establishing a manufacturing site for API production in the US.
The DMF of this API is not referenced yet in any NDA, but might be referenced in IND for Phase III trial.
Is there anyway to have the manufacturing site inspected by FDA? The inspection will enable sales in other jurisdictions oversees (e.g., EU).
Thank you.