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.

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.