Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar
Form 483 issued September 20, 2019 · Tarapur, India
- Inspection
- Sep 16 – Sep 20, 2019
- Investigator
- Unnee Ranjan
- Observations
- 3
- Pages
- 3
- FEI number
- 3002807512
In short: On September 20, 2019, FDA issued a Form 483 with 3 observations to Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar in Tarapur, India (FEI 3002807512) after an inspection that ran Sep 16 – Sep 20, 2019. The investigator was Unnee Ranjan. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Batch production and control records do not include complete information relating to the production and…
- 03
There was a failure to handle and store cleaned utensils in a…
This inspection in context
Unnee Ranjan
30 documents · 2015–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in India.
The firmLupin Limited 7-142, M.I.D.C. Tarapur Via Boisar history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar?
FDA listed 3 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar?
Unnee Ranjan is named on this Form 483, for the inspection of Sep 16 – Sep 20, 2019. Each investigator has a profile showing what they cite most.
When was Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar inspected by FDA?
The inspection ran Sep 16 – Sep 20, 2019, and the Form 483 is dated September 20, 2019.
How do I get the full Form 483 for Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar?
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.