Alkem Laboratories has announced the conclusion of a recent US FDA inspection at its manufacturing unit located in Amaliya, Daman. The inspection, which took place between April 20, 2026, and May 1, 2026, resulted in the issuance of a Form 483 containing seven observations. The company has committed to addressing these findings within the required regulatory timeframe.
Inspection Outcome
The manufacturing facility operated by Alkem Laboratories in Amaliya, Daman, recently underwent an audit by the US Food and Drug Administration. The inspection process concluded on May 1, 2026, following a 12-day evaluation period that began on April 20, 2026.
Next Steps for Compliance
At the conclusion of the audit, the company received a Form 483, which lists seven observations identified by the regulators. Alkem Laboratories management has confirmed that they are actively working to address each of these observations. The company intends to submit its corrective and preventive action plan within the stipulated timeframe to ensure ongoing compliance with manufacturing standards.
Source: BSE
