FDA Quality Audits 21cfr820.22 - Audits by the head of the company not allowed

[Al Rosen]

Small companies don't have a chance!

According to FDAnews.com:

AUDITS CANNOT BE CONDUCTED BY THE HEAD OF THE COMPANY

The president of a company cannot conduct internal quality audits, the FDA told the Ludwig Medical President Gerald Ludwig in a recent warning letter.

Following a May inspection, the company, which manufactures sterile specimen traps, was issued a 483 for failure to conduct quality audits, among other things. According to the FDA, the company had not conducted a quality audit since 1991.

In a response letter to the agency, Ludwig proposed he be allowed to conduct a self-audit. The FDA rejected the proposal in an Aug. 13 warning letter, saying the proposal is not adequate because the Quality System Regulation (QSR) expressly prohibits such audits.

To see a copy of the Aug. 13 letter, go to http://www.fda.gov/foi/warning_letters/g4232d.pdf

How does the regulation prohibit this? It states:
Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited.

More FDA/Government BS.

[db]

Originally Posted by Al Rosen

Small companies don't have a chance! .... Etc.

I have seen this before also in ISO and QS. In all cases, the determination was that the President has direct responsibility and therefore, cannot audit. Also, in all cases, it was determined that others in the organization could audit, only the President was excluded.