USFDA Concludes Pre Approval Inspection at Enzene Biosciences Unit
New Delhi, February 16: Alkem Laboratories on Monday said the United States health regulator has issued a Form 483 with six observations following an inspection of the manufacturing facility of its wholly owned subsidiary Enzene Biosciences in Chakan.According to a regulatory filing, the US Food and Drug Administration completed a pre approval inspection at the facility on February 13, 2026.
At the end of the inspection, the US regulator issued a Form 483 citing six procedural observations.
No Data Integrity Observations Reported
Alkem Laboratories stated that there were zero observations related to data integrity, describing it as a critical validation of its quality systems and the reliability of its regulatory filings.The company added that Enzene Biosciences is preparing its response to the US regulator within the stipulated timeline. It has also initiated appropriate corrective and preventive actions in response to the observations.
What Form 483 Means
As per the USFDA, a Form 483 is issued to a company’s management at the conclusion of an inspection when investigators observe conditions that may constitute violations of the Food, Drug and Cosmetic Act and related laws.The issuance of Form 483 does not represent a final determination by the regulator, but outlines inspectional observations that require a response from the company.
Alkem Laboratories Share Price
Shares of Alkem Laboratories ended 1.37 per cent higher at Rs 5,475.55 apiece on the BSE on Monday.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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