Lupin Limited 15-B, Phase 1A, Verna Industrial Area
Form 483 issued February 8, 2019 · Verna, India
- Inspection
- Jan 28 – Feb 8, 2019
- Investigators
- Lata Mathew· Unnee Ranjan
- Observations
- 2
- Pages
- 4
- FEI number
- 3004819820
In short: On February 8, 2019, FDA issued a Form 483 with 2 observations to Lupin Limited 15-B, Phase 1A, Verna Industrial Area in Verna, India (FEI 3004819820) after an inspection that ran Jan 28 – Feb 8, 2019. The investigators were Lata Mathew and Unnee Ranjan. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.100 (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
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Lata Mathew
24 documents · 2017–2024
Cites 211.160 (general requirements) 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 211.192
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 2 observations on this Form 483, mostly about quality system and production. 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 15-B, Phase 1A, Verna Industrial Area?
Lata Mathew and Unnee Ranjan are named on this Form 483, for the inspection of Jan 28 – Feb 8, 2019. 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 Jan 28 – Feb 8, 2019, and the Form 483 is dated February 8, 2019.
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.