Shilpa Medicare's Bengaluru Unit Receives 5 USFDA Observations Following PAI
Hyderabad: Shilpa Medicare Limited has announced that the United States Food and Drug Administration (USFDA) conducted a Pre-Approval Inspection (PAI) at its Unit VI facility. The inspection concluded with the issuance of a USFDA Form 483 containing five observations.
The facility, located at Plot No. 29/A, Sompura, Phase 4, Avarehalli Industrial Area, Dabaspet, Bengaluru, Karnataka, was inspected from May 25, 2026 to May 29, 2026.
The inspection concluded with the issuance of a USFDA Form 483 containing five observations. The company clarified that all five observations are procedural in nature, none of them are repeat observations, and none are related to data integrity issues.
According to the filing, Unit VI is involved in the manufacturing, packaging, labelling, and testing of specialized finished dosage forms such as oral dispersible or dissolving films and transdermal patches.
The company further stated that Unit VI had previously undergone a USFDA Good Manufacturing Practice (GMP) inspection and currently holds a Voluntary Action Indicated (VAI) status, reflecting the facility’s regulatory compliance history. In addition to USFDA approval, the facility also holds accreditations from several international regulatory authorities including the European Medicines Agency (EMA), Saudi Arabia’s Saudi Food and Drug Authority (SFDA), the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), and Australia’s Therapeutic Goods Administration (TGA).
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The filing stated that the USFDA conducted the inspection at the formulation facility in Bengaluru and completed the inspection on May 29, 2026, after which the agency issued Form 483 with five procedural observations.
The company stated that it would submit a comprehensive response to the USFDA within the stipulated timeline while addressing each observation through appropriate corrective and preventive actions. It further reiterated its commitment to maintaining high standards of quality and regulatory compliance across all operations.
Shilpa Medicare also informed the stock exchanges that it does not expect the outcome of the inspection to have any material impact on its current business operations or existing supplies from the Dabaspet facility.
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