Lupin Limited
Form 483 issued September 16, 2025 · Nagpur, India
- Inspection
- Sep 8 – Sep 16, 2025
- Investigators
- Chad W. Rice· Hung H. Do· Sandra A. Boyd
- Observations
- 6
- Pages
- 8
- FEI number
- 3015392060
In short: On September 16, 2025, FDA issued a Form 483 with 6 observations to Lupin Limited in Nagpur, Maharashtra (FEI 3015392060) after an inspection that ran Sep 8 – Sep 16, 2025. The investigators were Chad W. Rice, Hung H. Do and Sandra A. Boyd. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 4 of 6 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Procedures designed to prevent microbiological contamination of ding products purporting to be sterile are not…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Chad W. Rice
8 documents · 2023–2026
Cites 211.113(a) (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lupin Limited?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Lupin Limited?
Chad W. Rice, Hung H. Do and Sandra A. Boyd are named on this Form 483, for the inspection of Sep 8 – Sep 16, 2025. Each investigator has a profile showing what they cite most.
When was Lupin Limited inspected by FDA?
The inspection ran Sep 8 – Sep 16, 2025, and the Form 483 is dated September 16, 2025.
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.