Lupin Limited
Form 483 issued February 8, 2019 · Verna, India
- Inspection
- Jan 28 – Feb 8, 2019
- Investigator
- Lata Mathew
- Observations
- 1
- Pages
- 4
- FEI number
- 3005819520
In short: On February 8, 2019, FDA issued a Form 483 with 1 observation to Lupin Limited in Verna, India (FEI 3005819520) after an inspection that ran Jan 28 – Feb 8, 2019. The investigator was Lata Mathew. 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×) · 211.160 (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 and the failure of a batch…
This inspection in context
Lata Mathew
24 documents · 2017–2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmLupin Limited history
The site's inspection history, in date order.
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?
Lata Mathew is named on this Form 483, for the inspection of Jan 28 – Feb 8, 2019. Each investigator has a profile showing what they cite most.
When was Lupin Limited inspected by FDA?
The inspection ran Jan 28 – Feb 8, 2019, and the Form 483 is dated February 8, 2019.
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.