Lupin Limited
Form 483 issued May 19, 2017 · Indore, India
- Inspection
- May 8 – May 19, 2017
- Investigators
- Darren S. Brown· Tamil Arasu
- Observations
- 1
- Pages
- 7
- FEI number
- 3007549629
In short: On May 19, 2017, FDA issued a Form 483 with 1 observation to Lupin Limited in Indore, India (FEI 3007549629) after an inspection that ran May 8 – May 19, 2017. The investigators were Darren S. Brown and Tamil Arasu. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lupin Limited?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Lupin Limited?
Darren S. Brown and Tamil Arasu are named on this Form 483, for the inspection of May 8 – May 19, 2017. Each investigator has a profile showing what they cite most.
When was Lupin Limited inspected by FDA?
The inspection ran May 8 – May 19, 2017, and the Form 483 is dated May 19, 2017.
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.