USFDA2 May 2026, 01:31 pm
Alkem Labs Receives Form 483 with 7 Observations from US FDA Inspection
AI Summary
Alkem Laboratories Ltd. announced that the US FDA conducted an inspection at its manufacturing facility in Amaliya, Daman, from April 20, 2026, to May 1, 2026. At the conclusion of the inspection, the company received Form 483 with seven observations. Alkem Laboratories plans to address these observations within the stipulated timeframe.
Key Highlights
- US FDA inspected Alkem's Amaliya, Daman manufacturing facility.
- The inspection took place from April 20, 2026, to May 1, 2026.
- Alkem received Form 483 with seven observations at the end of the inspection.
- The company will address the observations within the given timeframe.
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