New Delhi, May 3 Pharmaceutical major Alkem Laboratories has come under regulatory scrutiny after the United States Food and Drug Administration (USFDA) issued inspectional observations at its manufacturing facility in Amaliya, Daman, following a recent audit.
The inspection, conducted over 12 days from April 20 to May 1, concluded with the issuance of a Form 483, in which the US regulator flagged seven observations.
A Form 483, formally known as a “Notice of Inspectional Observations,” is issued when investigators identify conditions that may potentially violate provisions of the Food, Drug and Cosmetic Act, particularly those related to manufacturing practices, quality systems, or product safety.
While the company acknowledged receiving the observations, it did not disclose specific details about the issues raised by the regulator.
Alkem Laboratories said it would respond to all seven observations within the stipulated timeline.
The development was formally communicated to the BSE Limited and the National Stock Exchange of India on May 2, 2026, in line with regulatory disclosure requirements.
The latest scrutiny comes weeks after a positive regulatory milestone for the company. In March, Alkem Laboratories announced that its Daman facility had received a Good Manufacturing Practice (GMP) compliance certificate from the Malta Medicines Authority.
The certification followed an inspection conducted on December 9, 2025, and confirmed that the facility met European Union GMP standards. The certificate is valid for a period of three years.
Meanwhile, last month, US health regulator issued a 'Form 483' with three observations to drug maker Lupin.
In a regulatory filing, the pharmaceutical company said that the inspection by the US Food and Drug Administration (USFDA) was conducted this week between April 13 and April 17.
"The inspection was completed with the issuance of a Form 483 carrying three observations," the drug maker said.
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