The inspection, conducted from March 10 to March 14, 2025, concluded without any Form 483 being issued. This marks the second consecutive clean inspection at the site.
“This is to inform you that the United States Food and Drugs Administration (USFDA) has conducted an inspection at Unit-2 of Shilpa Pharma Lifesciences Limited, located at Raichur, from March 10-14, 2025. The inspection was closed with ZERO observations.
This is the second consecutive ZERO 483 inspection from USFDA at this site,” Shilpa Medicare said in a regulatory filing.
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Last week, Shilpa Medicare announced that the United States Food and Drug Administration (USFDA) has completed an inspection at Unit-1 of its wholly owned subsidiary, Shilpa Pharma Lifesciences Ltd, in Raichur.
“This is to inform you that the United States Food and Drugs Administration (USFDA) has conducted an inspection at Unit-1 of Shilpa Pharma Lifesciences Limited, located at Raichur, from March 3-7, 2025. On the conclusion of the inspection, we received 1 (one) observation in form 483, which is procedural in nature,” Shilpa Medicare said in a regulatory filing.
The inspection, conducted from March 3 to March 7, 2025, resulted in one procedural observation under Form 483. The company stated that it will work closely with the USFDA to address the observation within the stipulated timeframe. “The company will closely work with the agency and remain committed to address this observation comprehensively within stipulated time,” it added.
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On Thursday (March 13), shares of Shilpa Medicare Ltd ended at ₹628.20, down by ₹17.10, or 2.65%, on the BSE.