Lupin Limited
Form 483 issued July 8, 2025 · Pithampur, India
- Inspection
- Jul 8, 2025
- Investigators
- Lisa L. Flores· Rafeeq Habeeb
- Observations
- 4
- Pages
- 7
- FEI number
- 3007549629
In short: On July 8, 2025, FDA issued a Form 483 with 4 observations to Lupin Limited in Pithampur, Madhya Pradesh (FEI 3007549629) after an inspection that ran Jul 8, 2025. The investigators were Lisa L. Flores and Rafeeq Habeeb. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 03
Written procedtues are not established and followed that describe the examinations to be conducted on appropriate…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Lisa L. Flores
20 documents · 2012–2026
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lupin Limited?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Lupin Limited?
Lisa L. Flores and Rafeeq Habeeb are named on this Form 483, for the inspection of Jul 8, 2025. Each investigator has a profile showing what they cite most.
When was Lupin Limited inspected by FDA?
The inspection ran Jul 8, 2025, and the Form 483 is dated July 8, 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.