Lupin Limited
Form 483 issued January 10, 2020 · Nagpur, India
- Inspection
- Jan 6 – Jan 10, 2020
- Investigator
- Marcellinus D. Dordunoo
- Observations
- 2
- Pages
- 6
- FEI number
- 3009843207
In short: On January 10, 2020, FDA issued a Form 483 with 2 observations to Lupin Limited in Nagpur, Maharashtra (FEI 3009843207) after an inspection that ran Jan 6 – Jan 10, 2020. The investigator was Marcellinus D. Dordunoo. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.160 (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 and the failure of a batch…
- 02
Established laboratory control mechanisms are not followed and documented at…
This inspection in context
Marcellinus D. Dordunoo
21 documents · 2017–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Maryland.
The firmLupin Limited history
All 2 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?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. 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?
Marcellinus D. Dordunoo is named on this Form 483, for the inspection of Jan 6 – Jan 10, 2020. Each investigator has a profile showing what they cite most.
When was Lupin Limited inspected by FDA?
The inspection ran Jan 6 – Jan 10, 2020, and the Form 483 is dated January 10, 2020.
How do I get the full Form 483 for Lupin Limited?
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.