Lupin Limited
Form 483 issued October 29, 2022 · Nagpur, India
- Observations
- 5
- Pages
- 4
- FEI number
- 3015392060
In short: On October 29, 2022, FDA issued a Form 483 with 5 observations to Lupin Limited in Nagpur, Maharashtra (FEI 3015392060). Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 4 of 5 observations.
Most cited: 21 CFR 211.42 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient in that floors, walls, ceilings are not smooth and/or hard surfaces…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Questions about this 483
What did FDA find at Lupin Limited?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
When was Lupin Limited inspected by FDA?
This Form 483 is dated October 29, 2022.
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.