Sun Pharmaceuticals Industries Ltd.
Form 483 issued March 29, 2019 · Dadra, India
- Inspection
- Mar 22 – Mar 29, 2019
- Investigators
- Angela E. Glenn· Cheryl Clausen
- Observations
- 11
- Pages
- 10
- FEI number
- 3004561553
In short: On March 29, 2019, FDA issued a Form 483 with 11 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 Mar 22 – Mar 29, 2019. The investigators were Angela E. Glenn and Cheryl Clausen. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
The quality control unit lacks authority to fully investigate…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Angela E. Glenn
10 documents · 2016–2024
Cites 211.160 (general requirements) 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 211.25(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sun Pharmaceuticals Industries Ltd.?
FDA listed 11 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceuticals Industries Ltd.?
Angela E. Glenn and Cheryl Clausen are named on this Form 483, for the inspection of Mar 22 – Mar 29, 2019. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceuticals Industries Ltd. inspected by FDA?
The inspection ran Mar 22 – Mar 29, 2019, and the Form 483 is dated March 29, 2019.
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.