USFDA issues Form-483 with 5 observations to Ajanta Pharma's Paithan facility

New Delhi: Ajanta Pharma on Wednesday said the US health regulator has issued Form-483 with five observations to its Paithan facility in Maharashtra following an inspection.

The USFDA conducted an inspection at the company's manufacturing facility at Paithan during April 13-21, 2026 and closed with the issuance of Form-483 with five observations, Ajanta Pharma said in a regulatory filing.

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The company will respond to the USFDA within the stipulated timeline, it added.

As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.