Lupin Limited 15-B, Phase 1A, Verna Industrial Area
Form 483 issued September 18, 2021 · Verna, India
- Inspection
- Sep 6 – Sep 18, 2021
- Observations
- 7
- Pages
- 8
- FEI number
- 3004819820
In short: On September 18, 2021, FDA issued a Form 483 with 7 observations to Lupin Limited 15-B, Phase 1A, Verna Industrial Area in Verna, Goa (FEI 3004819820) after an inspection that ran Sep 6 – Sep 18, 2021. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations of an unexplained discrepancy did not extend to other drug products that may have been…
- 02
In process materials are not tested for strength and approved or rejected by the quality control…
- 03
Your examination and testing of samples did not assure that the drug product and in-process…
- 04
Establishment of the reliability of component supplier’s report of analysis is deficient in that the test…
This inspection in context
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 production. The opening words of each observation are shown on this page.
When was Lupin Limited 15-B, Phase 1A, Verna Industrial Area inspected by FDA?
The inspection ran Sep 6 – Sep 18, 2021, and the Form 483 is dated September 18, 2021.
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.