Dr Reddys Laboratories Ltd has informed stock exchanges that the audit of Company's formulation manufacturing facilty at Duwada, Visakhapatnam, by the US FDA, has been completed on March 08, 2017. The Company have been issued a Form 483 with 13 observations, which the Company is addressing.
For the benefit of readers, we are providing additional information on Form 482 by USFDA.
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 judgement 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 judgement, 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.
What is the purpose of an FDA Form 483?