Sun Pharmaceuticals Industries, Inc
Form 483 issued November 16, 2016 · S.A.S. Nagar, Mohali, India
- Inspection
- Nov 7 – Nov 16, 2016
- Investigators
- Daniel J. Roberts· Felix Maldonado· Steven D. Kehoe
- Observations
- 7
- Pages
- 4
- FEI number
- 3002807979
In short: On November 16, 2016, FDA issued a Form 483 with 7 observations to Sun Pharmaceuticals Industries, Inc in S.A.S. Nagar, Mohali, MohalL Punjab (FEI 3002807979) after an inspection that ran Nov 7 – Nov 16, 2016. The investigators were Daniel J. Roberts, Felix Maldonado and Steven D. Kehoe. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
Appropriate controls are not exercised over-computers or related systems to assure that changes in master production…
- 04
Examination and testing of samples is not done to assure that in-process…
This inspection in context
Daniel J. Roberts
14 documents · 2011–2017
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 7 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceuticals Industries, Inc?
Daniel J. Roberts, Felix Maldonado and Steven D. Kehoe are named on this Form 483, for the inspection of Nov 7 – Nov 16, 2016. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceuticals Industries, Inc inspected by FDA?
The inspection ran Nov 7 – Nov 16, 2016, and the Form 483 is dated November 16, 2016.
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.