Sun Pharmaceutical Medicare Limited
Form 483 issued July 13, 2023 · Halol Panchmahal, India
- Inspection
- Jul 3 – Jul 13, 2023
- Observations
- 1
- Pages
- 2
- FEI number
- 3002957541
In short: On July 13, 2023, FDA issued a Form 483 with 1 observation to Sun Pharmaceutical Medicare Limited in Halol Panchmahal, Gujarat (FEI 3002957541) after an inspection that ran Jul 3 – Jul 13, 2023. 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 observation- 01
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
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.
When was Sun Pharmaceutical Medicare Limited inspected by FDA?
The inspection ran Jul 3 – Jul 13, 2023, and the Form 483 is dated July 13, 2023.
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.