Key Points
In a warning letter to companys Managing Director Sharvil Patel, the US Food and Drug Administration (USFDA) noted that the drug maker failed to investigate contamination identified in drug products at its Jarod-based plant in Vadodara district...
The USFDA said it inspected the manufacturing facility from April 15 to 23, 2024...
Elaborating on the manufacturing issues at the facility, USFDA noted: Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed..
Your investigation failed to consider all impacted batches, all manufacturing equipment involved, and the adequacy of your testing methods used to release contaminated drug products, USFDA noted...
Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilisation processes, it added...
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