Strides Pharma Bengaluru Facility Receives Form 483 with 5 USFDA Observations
New Delhi: Strides Pharma Science has informed the stock exchanges that the United States Food and Drug Administration (USFDA) has issued a Form 483 with five observations following an inspection at the company's flagship manufacturing facility located in Bengaluru.
According to the company’s regulatory filing, the USFDA conducted a routine current Good Manufacturing Practices (cGMP) inspection at the Bengaluru facility from May 12, 2026 to May 20, 2026.
At the conclusion of the inspection, the US health regulator issued a Form 483 containing five observations related to the facility.
A Form 483 is issued by the USFDA when investigators identify conditions that may indicate possible deviations from manufacturing or regulatory compliance requirements during an inspection process. Strides Pharma Science stated that it will respond to the observations raised by the USFDA within the stipulated timeframe.
The company further said it would keep the stock exchanges informed regarding any further updates or developments related to the inspection matter. The disclosure was made under Regulation 30 of the SEBI Listing Regulations by the company.
