Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II
Form 483 issued October 18, 2018 · Pithampur, India
- Inspection
- Oct 8 – Oct 18, 2018
- Investigator
- Yasamin Ameri
- Observations
- 5
- Pages
- 6
- FEI number
- 3009107538
In short: On October 18, 2018, FDA issued a Form 483 with 5 observations to Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II in Pithampur, Madhya Pradesh (FEI 3009107538) after an inspection that ran Oct 8 – Oct 18, 2018. The investigator was Yasamin Ameri. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Facilities & equipment and materials account for 4 of 5 observations.
Most cited: 21 CFR 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Sampling procedures are deficient regarding sampling components from the top, middle, and…
This inspection in context
Yasamin Ameri
20 documents · 2015–2022
Cites 211.68 (automatic, mechanical, and electronic equipment) 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
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 5 observations on this Form 483, mostly about facilities & equipment, materials and production. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Lupin Limited Unit 3, Plot No. M-1, SEZ, Phase II?
Yasamin Ameri is named on this Form 483, for the inspection of Oct 8 – Oct 18, 2018. 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 Oct 8 – Oct 18, 2018, and the Form 483 is dated October 18, 2018.
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.