Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II
Form 483 issued July 17, 2025 · Pithampur, India
- Inspection
- Jul 7 – Jul 17, 2025
- Investigators
- Lisa L. Flores· Rafeeq Habeeb
- Observations
- 3
- Pages
- 2
- FEI number
- 3009107538
In short: On July 17, 2025, FDA issued a Form 483 with 3 observations to Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II in Pithampur, Madhya Pradesh (FEI 3009107538) after an inspection that ran Jul 7 – Jul 17, 2025. The investigators were Lisa L. Flores and Rafeeq Habeeb. Most observations concern materials and quality system.
At a glance
Materials and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Each component is not tested for conformity with all appropriate written specifications for…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Written procedures are not established that describe the in-process controls and examinations to be conducted on…
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 Unit 3, Plot No. M-1, SEZ, Phase II history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II?
FDA listed 3 observations on this Form 483, mostly about materials, quality system and production. The opening words of each observation are shown on this page.
Who inspected Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II?
Lisa L. Flores and Rafeeq Habeeb are named on this Form 483, for the inspection of Jul 7 – Jul 17, 2025. Each investigator has a profile showing what they cite most.
When was Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II inspected by FDA?
The inspection ran Jul 7 – Jul 17, 2025, and the Form 483 is dated July 17, 2025.
How do I get the full Form 483 for Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II?
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.