Sun Pharmaceutical Industries Ltd.
Form 483 issued May 9, 2022 · Halol, India
- Inspection
- Apr 26 – May 9, 2022
- Investigators
- Ileana Barreto-Pettit· Jose M. Cayuela· Saleem A. Akhtar
- Observations
- 10
- Pages
- 23
- FEI number
- 3002809586
In short: On May 9, 2022, FDA issued a Form 483 with 10 observations to Sun Pharmaceutical Industries Ltd. in Halol, India (FEI 3002809586) after an inspection that ran Apr 26 – May 9, 2022. The investigators were Ileana Barreto-Pettit, Jose M. Cayuela and Saleem A. Akhtar. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 7 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Ileana Barreto-Pettit
25 documents · 2001–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmSun Pharmaceutical Industries Ltd. history
All 11 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sun Pharmaceutical Industries Ltd.?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceutical Industries Ltd.?
Ileana Barreto-Pettit, Jose M. Cayuela and Saleem A. Akhtar are named on this Form 483, for the inspection of Apr 26 – May 9, 2022. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceutical Industries Ltd. inspected by FDA?
The inspection ran Apr 26 – May 9, 2022, and the Form 483 is dated May 9, 2022.
How do I get the full Form 483 for Sun Pharmaceutical Industries 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.