Sun Pharmaceutical Industries Ltd.
Form 483 issued December 1, 2016 · Halol, India
- Inspection
- Nov 17 – Dec 1, 2016
- Investigators
- Patric C. Klotzbuecher· Santos E. Camara
- Observations
- 1
- Pages
- 14
- FEI number
- 3002809586
In short: On December 1, 2016, FDA issued a Form 483 with 1 observation to Sun Pharmaceutical Industries Ltd. in Halol, India (FEI 3002809586) after an inspection that ran Nov 17 – Dec 1, 2016. The investigators were Patric C. Klotzbuecher and Santos E. Camara.
What FDA observed
Preview: the opening words of each observation- 01
Field Alert Reports were not submitted within three working days of receipt of information concerning bacteriological…
This inspection in context
Patric C. Klotzbuecher
13 documents · 2014–2019
Cites 211.160 (general requirements) 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.
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Questions about this 483
What did FDA find at Sun Pharmaceutical Industries Ltd.?
FDA listed 1 observation on this Form 483. The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceutical Industries Ltd.?
Patric C. Klotzbuecher and Santos E. Camara are named on this Form 483, for the inspection of Nov 17 – Dec 1, 2016. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceutical Industries Ltd. inspected by FDA?
The inspection ran Nov 17 – Dec 1, 2016, and the Form 483 is dated December 1, 2016.
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.