Fierce Pharma May 6, 2024
Zydus Lifesciences recently received its second Form 483 reprimand from the FDA within the span of one month. In the second write-up, the regulatory agency flagged issues ranging from unqualified employees performing sample collections to improper evaluations of drug batches.
The agency inspected the company’s site in Gujarat, India, between April 15 and April 23, finding ten observations of manufacturing procedural shortfalls. The FDA posted the more recent Form 483 on April 29.
According to the FDA, Zydus’ facility demonstrated inconsistencies with internal investigations, skirted sampling plans and skipped over procedures meant to prevent microbiological contamination of sterile drug products.
Plus, even after an investigation found cross-contamination in rejected batches, other drug lots produced on the same equipment were released...
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