“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.
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.