FDA Medical Device templates taken from 483’s and FDA warning letters. Some are so basic, it is alarming that there are persons in the industry so poorly informed. Others are pure complacency, with a drop of arrogance mixed in.
Individuals who conduct quality
audits have direct responsibility for the matters being audited, in
violation of 21 C.F.R. 820.22. Specifically, one [redacted] of the
individuals who audited manufacturing on 3/6/06 had direct
responsibility over the area he audited.
Medical device validation Have you have failed to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).
You have failed to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i).
You have failed to adequately establish and maintain the procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by FDA Medical Devices validation legislation.
You have failed to review, evaluate, and investigate any medical device complaint involving the possible failure of a device to meet any of its specifications, as required by 21 CFR 820.198(c).
During the inspection, the FDA investigator asked how the bulk medical device samples can be considered to be representative of the complete manufacturing process, including the filling operation. Our investigator was told that sampling procedure is used because First Priority has performed process validation testing on all products. However, our inspection revealed that none of the process validation studies reviewed, particularly for suspension and powder products, established a hold time between compounding and filling. FDA Warning Letters 15.
Individuals who conduct medical device qualification quality audits have direct responsibility for the matters being audited, in violation of 21 C.F.R. 820.22. Specifically, one [redacted] of the individuals who audited manufacturing on 3/6/06 had direct responsibility over the area he audited.