Lupin Limited 15-B, Phase 1A, Verna Industrial Area
Form 483 issued July 17, 2015 · Verna, India
- Inspection
- Jul 9 – Jul 17, 2015
- Investigators
- Charanjeet S. Jassal· Luis A. Dasta
- Observations
- 1
- Pages
- 5
- FEI number
- 3004819820
In short: On July 17, 2015, FDA issued a Form 483 with 1 observation to Lupin Limited 15-B, Phase 1A, Verna Industrial Area in Verna, India (FEI 3004819820) after an inspection that ran Jul 9 – Jul 17, 2015. The investigators were Charanjeet S. Jassal and Luis A. Dasta. 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×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug products failing to meet established specifications and quality control…
This inspection in context
Charanjeet S. Jassal
5 documents · 2015–2016
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmLupin Limited 15-B, Phase 1A, Verna Industrial Area history
All 6 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 Lupin Limited 15-B, Phase 1A, Verna Industrial Area?
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 Lupin Limited 15-B, Phase 1A, Verna Industrial Area?
Charanjeet S. Jassal and Luis A. Dasta are named on this Form 483, for the inspection of Jul 9 – Jul 17, 2015. Each investigator has a profile showing what they cite most.
When was Lupin Limited 15-B, Phase 1A, Verna Industrial Area inspected by FDA?
The inspection ran Jul 9 – Jul 17, 2015, and the Form 483 is dated July 17, 2015.
How do I get the full Form 483 for Lupin Limited 15-B, Phase 1A, Verna Industrial Area?
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.