Sun Pharmaceutical Industries Ltd.
Form 483 issued December 13, 2019 · Halol, India
- Inspection
- Dec 3 – Dec 13, 2019
- Investigators
- Dongping Dai· Jose E. Melendez· Kellia N. Hicks
- Observations
- 8
- Pages
- 16
- FEI number
- 3002809586
In short: On December 13, 2019, FDA issued a Form 483 with 8 observations to Sun Pharmaceutical Industries Ltd. in Halol, India (FEI 3002809586) after an inspection that ran Dec 3 – Dec 13, 2019. The investigators were Dongping Dai, Jose E. Melendez and Kellia N. Hicks. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and quality system account for 6 of 8 observations.
Most cited: 21 CFR 211.110(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Dongping Dai
1 document · 2019
Cites 211.110(a) (sampling and testing of in-process materials and drug products) 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 211.110(a)
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, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceutical Industries Ltd.?
Dongping Dai, Jose E. Melendez and Kellia N. Hicks are named on this Form 483, for the inspection of Dec 3 – Dec 13, 2019. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceutical Industries Ltd. inspected by FDA?
The inspection ran Dec 3 – Dec 13, 2019, and the Form 483 is dated December 13, 2019.
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.