Unannounced inspections, FDA [GxP / QC / QA]

posted by ElMaestro  – Denmark, 2023-12-19 09:54 (123 d 02:26 ago) – Posting: # 23795
Views: 710

Hi all,

See this article.

It concerns a letter sent by the US congress to FDA, polity asking the agency to answer a ton of questions related to possible lack of unannounced inspections of manufacturers in China and India. The letter can be found here.

Note the pleasant tone. "On July 18, 2023, the Committee sent you an oversight request letter seeking information and documents relevant to this ongoing investigation. To date, the FDA has not provided any response to the Committee."
Now, that's remarkable since FDA themselves are extremely demanding towards those entities that they oversee. If, as an inspectee, you don't meet an FDA deadline or fail to address an issue to FDA's satisfaction all manners of hell can break loose. Quickly. Here it sounds like FDA largely gave the finger to the congress which oversees FDA. Double standards? I am no lawyer and I could be entirely wrong, of course.
But the rest of the letter is interesting too. It revolves around inspections, shortages and the link between compliance and supply/demand trouble. If I am getting it right (and probably I am not) congress really seems to be taken by surprise by news coverage suggesting that FDA simply stopped overseas unannounced inspections. So there's a friendly reminder that the congress really would like FDA to dutifully answer the questions they were sent already months ago.
"In closing, the Committee is concerned that the Department of Health and Human Services
(HHS), including the FDA, has made a deliberate decision to understaff and under-resource its
ability to respond to oversight requests."

Yikes.

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
22,988 posts in 4,825 threads, 1,657 registered users;
97 visitors (0 registered, 97 guests [including 8 identified bots]).
Forum time: 13:21 CEST (Europe/Vienna)

The whole purpose of education is
to turn mirrors into windows.    Sydney J. Harris

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5