Shares of Alkem Laboratories experienced a 3% decline after the US Food and Drug Administration (USFDA) issued a Form 483 with 10 observations for its manufacturing facility in Baddi.
The drug firm disclosed that the USFDA conducted an inspection at the Baddi facility from March 19 to March 27, 2024. Following the inspection, Alkem Laboratories received the Form 483, listing the observations, as stated in a stock exchange filing.
A Form 483 serves as a record of observations made by USFDA inspectors during an inspection and is provided to the company at the conclusion of the assessment. It is not considered a final determination of compliance with Good Manufacturing Practices (GMP) by the FDA.
Upon receiving the Form 483, the company has a 15-day period to respond to the USFDA, outlining the corrective actions it intends to take to address the observations.
As of 10:27 am, the company’s shares were trading 3% lower at ₹4,854.00 on the NSE.
