Shilpa Medicare Limited
Form 483 issued May 29, 2026 · Bengaluru, India
- Inspection
- May 25 – May 29, 2026
- Observations
- 5
- Pages
- 6
- FEI number
- 3018694237
In short: On May 29, 2026, FDA issued a Form 483 with 5 observations to Shilpa Medicare Limited in Bengaluru, Karnataka (FEI 3018694237) after an inspection that ran May 25 – May 29, 2026. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Written records are not always made of…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Production records do not contain complete information relating to the production and…
This inspection in context
Questions about this 483
What did FDA find at Shilpa Medicare Limited?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
When was Shilpa Medicare Limited inspected by FDA?
The inspection ran May 25 – May 29, 2026, and the Form 483 is dated May 29, 2026.
How do I get the full Form 483 for Shilpa Medicare Limited?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.