Lupin Limited
Form 483 issued March 29, 2023 · Pithampur, India
- Inspection
- Mar 21 – Mar 29, 2023
- Investigators
- Eileen A. Liu· Yvins Dezan
- Observations
- 10
- Pages
- 13
- FEI number
- 3007549629
In short: On March 29, 2023, FDA issued a Form 483 with 10 observations to Lupin Limited in Pithampur, Distt. Dhar (FEI 3007549629) after an inspection that ran Mar 21 – Mar 29, 2023. The investigators were Eileen A. Liu and Yvins Dezan. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 7 of 10 observations.
Most cited: 21 CFR 211.192 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations of a failure of a batch or any of its components to meet any of…
- 02
(Repeat) There is a failure to th oroughly review any unexplained discrepancy and the failure of…
- 03
(Repeat) Written records of investigation of a dtug complaint do not include the findings of the…
- 04
(Repeat) Employees engaged in the manufacture, processing, packing and holding of a drug product lack the…
This inspection in context
Eileen A. Liu
41 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmLupin Limited history
All 5 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 10 observations on this Form 483, mostly about quality system, facilities & equipment 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?
Eileen A. Liu and Yvins Dezan are named on this Form 483, for the inspection of Mar 21 – Mar 29, 2023. Each investigator has a profile showing what they cite most.
When was Lupin Limited inspected by FDA?
The inspection ran Mar 21 – Mar 29, 2023, and the Form 483 is dated March 29, 2023.
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.