Sun Pharmaceutical Industries Ltd.
Form 483 issued June 2, 2025 · Halol, India
- Inspection
- Jun 2, 2025
- Investigators
- Justin A. Boyd· Lisa L. Flores· Pratik S. Upadhyay
- Observations
- 8
- Pages
- 19
- FEI number
- 3002809586
In short: On June 2, 2025, FDA issued a Form 483 with 8 observations to Sun Pharmaceutical Industries Ltd. in Halol, Gujarat (FEI 3002809586) after an inspection that ran Jun 2, 2025. The investigators were Justin A. Boyd, Lisa L. Flores and Pratik S. Upadhyay. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 6 of 8 observations.
Most cited: 21 CFR 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has…
- 04
Equipment used in the manufacture, processing, packing or holding of diug products is not of appropriate…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sun Pharmaceutical Industries Ltd.?
FDA listed 8 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceutical Industries Ltd.?
Justin A. Boyd, Lisa L. Flores and Pratik S. Upadhyay are named on this Form 483, for the inspection of Jun 2, 2025. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceutical Industries Ltd. inspected by FDA?
The inspection ran Jun 2, 2025, and the Form 483 is dated June 2, 2025.
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.