Sun Pharmaceuticals Industries Ltd.
Form 483 issued December 15, 2023 · Dadra, India
- Inspection
- Dec 4 – Dec 15, 2023
- Investigator
- Pratik S. Upadhyay
- Observations
- 6
- Pages
- 18
- FEI number
- 3004561553
In short: On December 15, 2023, FDA issued a Form 483 with 6 observations to Sun Pharmaceuticals Industries Ltd. in Dadra, Union Territory of Dadra and Nagar Haveli and Daman and Diu (FEI 3004561553) after an inspection that ran Dec 4 – Dec 15, 2023. The investigator was Pratik S. Upadhyay. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmSun Pharmaceuticals Industries Ltd. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sun Pharmaceuticals Industries Ltd.?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceuticals Industries Ltd.?
Pratik S. Upadhyay is named on this Form 483, for the inspection of Dec 4 – Dec 15, 2023. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceuticals Industries Ltd. inspected by FDA?
The inspection ran Dec 4 – Dec 15, 2023, and the Form 483 is dated December 15, 2023.
How do I get the full Form 483 for Sun Pharmaceuticals 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.