Date: 30 May 2026
Regulatory Inspection Disclosure
USFDA Inspection Details
- Authority: United States Food and Drug Administration (USFDA), USA
- Facility Inspected: Shilpa Medicare Limited, Unit VI, located at Plot No.29/A, Sompura, Phase 4, Avarehalli Industrial Area, Dabaspet, Bengaluru, Karnataka
- Inspection Type: Pre-Approval Inspection (PAI)
- Inspection Period: 25 May 2026 to 29 May 2026
- Inspection Conclusion Date: 29 May 2026
- Outcome: Issuance of FDA Form 483
- Observations: 5 (five) procedural observations
- Nature of Observations: Procedural in nature. None were categorized as repeat observations and none are related to data integrity.
- Date of Receipt of Communication: 29 May 2026
Facility Profile & Regulatory History
- Facility Operations: Involved in manufacturing, packaging, labelling, and testing of specialized finished dosage forms, specifically oral dispersible/dissolving films and transdermal patches.
- Previous USFDA Status: The facility had previously undergone a USFDA GMP inspection and holds a Voluntary Action Indicated (VAI) status.
- Other Accreditations: The facility holds accreditations from Europe- EMA, Saudi Arabia-SFDA, UK-MHRA, and Australia-TGA.
Company Response & Impact Assessment
- Company Action: Shilpa Medicare Limited shall respond comprehensively to the procedural observations within the stipulated time.
- Stated Impact: The company does not expect this development to have any material impact on its current business operations or existing supplies from this facility.
Compliance & Disclosure
- SEBI Regulation: This intimation is made pursuant to Regulation 30 of the SEBI (LODR) Regulations, 2015.
- Referenced Circular: SEBI Circular No. SEBI/HO/49/14/14(7)2025-CFD-POD2/I/3762/2026 dated 30th January 2026.
Not Specified: KMP / Board / Auditor Changes, Dividend Declaration, Board Meeting Outcomes, Financial Results, Auditor’s Report, Disinvestment / Strategic Actions, Media Release / Investor Communication, Other Operational / Legal / Strategic Disclosures.