Sun Pharmaceutical Medicare Limited
Form 483 issued February 5, 2019 · Halol, India
- Inspection
- Jan 28 – Feb 5, 2019
- Investigator
- Tamil Arasu
- Observations
- 1
- Pages
- 3
- FEI number
- 3002957541
In short: On February 5, 2019, FDA issued a Form 483 with 1 observation to Sun Pharmaceutical Medicare Limited in Halol, Gujarat (FEI 3002957541) after an inspection that ran Jan 28 – Feb 5, 2019. The investigator was Tamil Arasu. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 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
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Tamil Arasu
27 documents · 2011–2025
Cites 211.192 (production record review) 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 211.192
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 quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceutical Medicare Limited?
Tamil Arasu is named on this Form 483, for the inspection of Jan 28 – Feb 5, 2019. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceutical Medicare Limited inspected by FDA?
The inspection ran Jan 28 – Feb 5, 2019, and the Form 483 is dated February 5, 2019.
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.