483
Aurobindo Pharma LimitedAurobindo Pharma Limited – FDA 483, Sep 29, 2023
Record Details
Aurobindo Pharma Limited, Unit-VI in Penapur, India, was inspected from September 22-29, 2023, and received one observation. The firm failed to establish adequate control procedures to monitor manufacturing processes, specifically regarding the management of packaging hold times. This is a repeat observation, indicating a persistent issue with ensuring product quality and process control.
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ID · 0a8f426c-7b66-416c-8ea8-43743e6eea6f
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