Sun Pharmaceuticals Industries, Inc
Form 483 issued February 7, 2020 · Mohali, India
- Inspection
- Feb 3 – Feb 7, 2020
- Investigators
- Jeffrey P. Raimondi· Philip F. Istafanos
- Observations
- 1
- Pages
- 1
- FEI number
- 3002807979
In short: On February 7, 2020, FDA issued a Form 483 with 1 observation to Sun Pharmaceuticals Industries, Inc in Mohali, Punjab (FEI 3002807979) after an inspection that ran Feb 3 – Feb 7, 2020. The investigators were Jeffrey P. Raimondi and Philip F. Istafanos. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Each batch of drug product required to be free of objectionable microorganisms is not tested…
This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmSun Pharmaceuticals Industries, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sun Pharmaceuticals Industries, Inc?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceuticals Industries, Inc?
Jeffrey P. Raimondi and Philip F. Istafanos are named on this Form 483, for the inspection of Feb 3 – Feb 7, 2020. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceuticals Industries, Inc inspected by FDA?
The inspection ran Feb 3 – Feb 7, 2020, and the Form 483 is dated February 7, 2020.
How do I get the full Form 483 for Sun Pharmaceuticals Industries, Inc?
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.