Sun Pharmaceutical Medicare Limited
Form 483 issued February 27, 2024 · Halol Panchmahal, India
- Inspection
- Feb 19 – Feb 27, 2024
- Investigator
- Junho Pak
- Observations
- 3
- Pages
- 4
- FEI number
- 3002957541
In short: On February 27, 2024, FDA issued a Form 483 with 3 observations to Sun Pharmaceutical Medicare Limited in Halol Panchmahal, Gujarat (FEI 3002957541) after an inspection that ran Feb 19 – Feb 27, 2024. The investigator was Junho Pak. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 3 observations.
Most cited: 21 CFR 211.113 (1×) · 211.192 (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…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Production equipment required for commercial manufacturing has not been identified…
This inspection in context
Junho Pak
28 documents · 2012–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 3 observations on this Form 483, mostly about production and quality system. 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?
Junho Pak is named on this Form 483, for the inspection of Feb 19 – Feb 27, 2024. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceutical Medicare Limited inspected by FDA?
The inspection ran Feb 19 – Feb 27, 2024, and the Form 483 is dated February 27, 2024.
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.