Lupin Limited 15-B, Phase 1A, Verna Industrial Area
Form 483 issued November 10, 2011 · Verna, Salcette, Goa, India
- Inspection
- Nov 10 – Nov 21, 2025
- Investigators
- Pratik S. Upadhyay· Tamil Arasu
- Observations
- 7
- Pages
- 19
- FEI number
- 3004819820
In short: On November 10, 2011, FDA issued a Form 483 with 7 observations to Lupin Limited 15-B, Phase 1A, Verna Industrial Area in Verna, Salcette, Goa, India (FEI 3004819820) after an inspection that ran Nov 10 – Nov 21, 2025. The investigators were Pratik S. Upadhyay and Tamil Arasu. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 6 of 7 observations.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 03
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
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 211.22
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 7 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Lupin Limited 15-B, Phase 1A, Verna Industrial Area?
Pratik S. Upadhyay and Tamil Arasu are named on this Form 483, for the inspection of Nov 10 – Nov 21, 2025. 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 Nov 10 – Nov 21, 2025, and the Form 483 is dated November 10, 2011.
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.