USFDA30 May 2026, 03:51 pm
Shilpa Medicare Unit VI Receives USFDA Form 483 With 5 Observations
AI Summary
Shilpa Medicare Ltd's Unit VI in Dabaspet, Bengaluru, underwent a USFDA Pre-Approval Inspection (PAI) from May 25-29, 2026. The inspection concluded with the issuance of a Form 483 containing 5 procedural observations, none of which are repeat observations or related to data integrity. The company will respond to the observations within the stipulated time and does not anticipate any material impact on current business operations or existing supplies. Unit VI holds accreditations from Europe- EMA, Saudi Arabia-SFDA, UK-MHRA, and Australia- TGA.
Key Highlights
- USFDA conducted a Pre-Approval Inspection at Shilpa Medicare's Unit VI.
- The inspection resulted in a Form 483 with 5 procedural observations.
- No observations were categorized as repeat or related to data integrity.
- Shilpa Medicare expects no material impact on business operations.
- Unit VI holds multiple international accreditations including EMA, SFDA, MHRA and TGA.
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