Strides Pharma Gets Three USFDA Observations Following Alathur Facility Inspection
New Delhi: Strides Pharma Science Limited has informed that the United States Food and Drug Administration (USFDA) issued a Form 483 with three observations following an inspection of its formulations facility at Alathur, Chennai.
A routine current Good Manufacturing Practices (cGMP) inspection was conducted by the United States Food and Drug Administration (USFDA) at the Company's Formulations Facility at Alathur, Chennai during the period from September 2, 2026 to September 11, 2026.
At the conclusion of the inspection, the USFDA has issued a Form 483 with three observations.
The company said it would respond to the observations within the stipulated time.
"Company will respond to these observations to USFDA within the stipulated time. We will keep the stock exchanges informed if there is any further update in this matter." Strides Pharma Science added.
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