“Make GMP Training Stick” – That’s one of the most popular requests from our clients. Of course, there are lots of turn-key, canned GMP training courses, available and for the most part they are OK. Except, that they don’t stick. If you’re not sure, look at your Laboratory OOS and GMP Discrepancy metrics. Now, we know that ‘Human Error” is the most loved “root-cause” for most laboratory and manufacturing investigations. The corrective action seems so easy too -retraining.
When a company receives a warning letter, it is usually an exciting event – in every sense of the word. The letter could show up unexpectedly. It does not matter if you have spoken with the FDA investigator ‘just last Thursday’ and ‘everything looked good’. It is also entirely possible that your company was expecting it (depending on how bad things are going with the FDA and how open they were with you during their visit).
Q: When is an FDA Form 483 issued?
A: An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant. Observations are made when in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.
The number one reason for getting a 483 or a Warning Letter from the FDA is:
The responsibilities and procedures applicable to the quality control unit are not in writing or fully followed. [CFR 211.22(d)].