Sun Pharmaceutical Industries Ltd.
Form 483 issued February 23, 2018 · Halol, India
- Inspection
- Feb 12 – Feb 23, 2018
- Investigators
- Kellia N. Hicks· Parul M. Patel· Scott Ballard
- Observations
- 1
- Pages
- 4
- FEI number
- 3002809586
In short: On February 23, 2018, FDA issued a Form 483 with 1 observation to Sun Pharmaceutical Industries Ltd. in Halol, Gujarat (FEI 3002809586) after an inspection that ran Feb 12 – Feb 23, 2018. The investigators were Kellia N. Hicks, Parul M. Patel and Scott Ballard. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42(c)(10) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
This inspection in context
Kellia N. Hicks
28 documents · 2017–2025
Cites 211.192 (production record review) 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 211.42(c)(10)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sun Pharmaceutical Industries Ltd.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. 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.?
Kellia N. Hicks, Parul M. Patel and Scott Ballard are named on this Form 483, for the inspection of Feb 12 – Feb 23, 2018. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceutical Industries Ltd. inspected by FDA?
The inspection ran Feb 12 – Feb 23, 2018, and the Form 483 is dated February 23, 2018.
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.