Sun Pharmaceuticals Industries, Inc
Form 483 issued August 12, 2022 · Mohali, India
- Inspection
- Aug 3 – Aug 12, 2022
- Investigators
- Jonah S. Ufferfilge· Justin A. Boyd· Teresa I. Navas
- Observations
- 6
- Pages
- 8
- FEI number
- 3002807979
In short: On August 12, 2022, FDA issued a Form 483 with 6 observations to Sun Pharmaceuticals Industries, Inc in Mohali, Punjab (FEI 3002807979) after an inspection that ran Aug 3 – Aug 12, 2022. The investigators were Jonah S. Ufferfilge, Justin A. Boyd and Teresa I. Navas. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Established sampling plans, test procedures and laboratory control mechanisms are not documented at the time of…
- 03
Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and…
- 04
Laboratory records are deficient in that they do not include a complete record of all…
This inspection in context
Jonah S. Ufferfilge
17 documents · 2019–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Connecticut.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sun Pharmaceuticals Industries, Inc?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceuticals Industries, Inc?
Jonah S. Ufferfilge, Justin A. Boyd and Teresa I. Navas are named on this Form 483, for the inspection of Aug 3 – Aug 12, 2022. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceuticals Industries, Inc inspected by FDA?
The inspection ran Aug 3 – Aug 12, 2022, and the Form 483 is dated August 12, 2022.
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.