I thought I would share a sampling of a take from a recent warning letter from the
“4. Failure of the quality control unit to conduct an adequate investigation of any unexplained discrepancy whether or not the batch has been distributed as required by 21 CFR 211.192. The current inspection revealed that your firm received three complaints: one of a burning sensation from the gas (received November 30, 2004); one that the oxygen in the tanks gave the consumer headaches (received February 2004); and, one complaint of a diesel smell in four oxygen tanks received (received January 2004). The inspection revealed that in all three cases your firm reportedly conducted USP testing on the cylinders, but failed to perform testing for impurities.”
I note this, as this is a recent warning letter from the FDA, which helps people in the industry be aware of the current FDA trends! Very helpful information when you are trying to determine what your respective firm should focus on in terms of compliance issues.
Michael J. Gregor