Sun Pharmaceutical Ltd
Form 483 issued January 24, 2020 · Ahilyanagar, India
- Inspection
- Jan 20 – Jan 24, 2020
- Investigator
- Nadeem I. Chaudhry
- Observations
- 1
- Pages
- 1
- FEI number
- 3003227153
In short: On January 24, 2020, FDA issued a Form 483 with 1 observation to Sun Pharmaceutical Ltd in Ahilyanagar, Maharashtra (FEI 3003227153) after an inspection that ran Jan 20 – Jan 24, 2020. The investigator was Nadeem I. Chaudhry. Most observations concern materials; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.80 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and written procedures for adequate control over temperature is not provided when appropriate for the…
This inspection in context
Nadeem I. Chaudhry
6 documents · 2010–2020
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in India.
The firmSun Pharmaceutical Ltd history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sun Pharmaceutical Ltd?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceutical Ltd?
Nadeem I. Chaudhry is named on this Form 483, for the inspection of Jan 20 – Jan 24, 2020. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceutical Ltd inspected by FDA?
The inspection ran Jan 20 – Jan 24, 2020, and the Form 483 is dated January 24, 2020.
How do I get the full Form 483 for Sun Pharmaceutical Ltd?
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.