USFDA Flags Compliance Gaps at Alkem's Daman Plant, Issues 7 Observations
New Delhi: Alkem Laboratories Limited has received seven observations in a Form 483 issued by the US Food and Drug Administration (USFDA) following an inspection at its manufacturing facility located at Amaliya, Daman, conducted from April 20, 2026 to May 1, 2026.
As per the company’s official communication dated May 2, 2026, the inspection was carried out at the Amaliya, Daman plant and concluded with the issuance of Form 483 containing seven observations.
The company stated that it will address these observations within the stipulated timeframe set by the regulator.
Form 483 is issued by the US FDA at the end of inspections to notify companies of observed conditions that may require corrective actions. Such observations are typically related to compliance and quality systems and are expected to be addressed through appropriate corrective and preventive measures.
The inspection forms part of routine regulatory oversight by the US FDA to ensure that pharmaceutical manufacturing facilities comply with required standards for products intended for the US market.
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