Aurobindo Pharma LimitedSeptember 29, 2023

FDA 483 - Aurobindo Pharma Limited - September 29, 2023

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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.

Company: Aurobindo Pharma Limited
Inspection Date: September 29, 2023
Product Type: Drugs
Office: Center for Drug Evaluation and Research
People: Brandy N. Lepage (Consumer Safety Officer)
Jennifer L. Huntington

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ID · 0a8f426c-7b66-416c-8ea8-43743e6eea6f