Sun Pharmaceutical Medicare Limited
Form 483 issued September 19, 2025 · Halol, India
- Inspection
- Sep 8 – Sep 19, 2025
- Investigators
- Claudia M. Perez-Kasmarski· Eileen A. Liu
- Observations
- 1
- Pages
- 8
- FEI number
- 3002957541
In short: On September 19, 2025, FDA issued a Form 483 with 1 observation to Sun Pharmaceutical Medicare Limited in Halol, India (FEI 3002957541) after an inspection that ran Sep 8 – Sep 19, 2025. The investigators were Claudia M. Perez-Kasmarski and Eileen A. Liu. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
This inspection in context
Claudia M. Perez-Kasmarski
11 documents · 2020–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmSun Pharmaceutical Medicare Limited history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sun Pharmaceutical Medicare Limited?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceutical Medicare Limited?
Claudia M. Perez-Kasmarski and Eileen A. Liu are named on this Form 483, for the inspection of Sep 8 – Sep 19, 2025. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceutical Medicare Limited inspected by FDA?
The inspection ran Sep 8 – Sep 19, 2025, and the Form 483 is dated September 19, 2025.
How do I get the full Form 483 for Sun Pharmaceutical 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.