Sun Pharmaceutical Ltd
Form 483 issued June 19, 2015 · Maharashtra, India
- Inspection
- Jun 16 – Jun 19, 2015
- Investigator
- Dinesh Shah
- Observations
- 2
- Pages
- 2
- FEI number
- 3003227153
In short: On June 19, 2015, FDA issued a Form 483 with 2 observations to Sun Pharmaceutical Ltd in Maharashtra, India (FEI 3003227153) after an inspection that ran Jun 16 – Jun 19, 2015. The investigator was Dinesh Shah. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.68 (1×) · 211.166 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Computerized systems are not…
- 02
Standard Operating Procedures are…
This inspection in context
Dinesh Shah
1 document · 2015
Cites 211.166 (stability testing) 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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sun Pharmaceutical Ltd?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceutical Ltd?
Dinesh Shah is named on this Form 483, for the inspection of Jun 16 – Jun 19, 2015. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceutical Ltd inspected by FDA?
The inspection ran Jun 16 – Jun 19, 2015, and the Form 483 is dated June 19, 2015.
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.