Shilpa Pharma Lifesciences Unit 1 gets EIR from USFDA
Karnataka: Shilpa Pharma Lifesciences, a 100% subsidiary of Shilpa Medicare Limited, has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for Unit-1.
The site is classified as VAI by the USFDA. Voluntary action indicated (VAI) means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
The inspection was carried out between March 3-7, 2025.
"This is to inform you that Shilpa Medicare Limited’s 100% subsidiary, Shilpa Pharma Lifesciences Limited, Unit-1 received EIR from USFDA and the site is classified as VAI," the Company informed in a BSE filing.
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In March, the facility had initially received one observation in form 483 from the USFDA. An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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Shilpa is an integrated pharmaceutical group with business interests in niche Oncology & Non-oncology APIs, Peptides, Polymers, differentiated finished dosage formulations including novel injectables, orally dispersible films & transdermal patches along with carefully crafted biological portfolio. Shilpa also provides end-to-end CDMO services to global pharmaceutical companies across all its business segments based on its R&D and manufacturing capabilities backed by four R&D units and seven manufacturing facilities.
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