Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II
Form 483 issued June 16, 2017 · Pithampur, India
- Inspection
- Jun 12 – Jun 16, 2017
- Investigators
- Doan T. Nguyen· Zhigang Sun
- Observations
- 1
- Pages
- 4
- FEI number
- 3009107538
In short: On June 16, 2017, FDA issued a Form 483 with 1 observation to Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II in Pithampur, India (FEI 3009107538) after an inspection that ran Jun 12 – Jun 16, 2017. The investigators were Doan T. Nguyen and Zhigang Sun. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
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 any unexplained discrepancy whether or not the batch…
This inspection in context
Doan T. Nguyen
8 documents · 2014–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Germany.
The firmLupin Limited Unit 3, Plot No. M-1, SEZ, Phase II 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 Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II?
Doan T. Nguyen and Zhigang Sun are named on this Form 483, for the inspection of Jun 12 – Jun 16, 2017. Each investigator has a profile showing what they cite most.
When was Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II inspected by FDA?
The inspection ran Jun 12 – Jun 16, 2017, and the Form 483 is dated June 16, 2017.
How do I get the full Form 483 for Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II?
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.