Lupin Limited
Form 483 issued July 11, 2023 · Nagpur, India
- Inspection
- Jul 3 – Jul 11, 2023
- Investigators
- Raquel Gonzalez Rivera· Saundrea A. Munroe
- Observations
- 2
- Pages
- 4
- FEI number
- 3009843207
In short: On July 11, 2023, FDA issued a Form 483 with 2 observations to Lupin Limited in Nagpur, Maharashtra (FEI 3009843207) after an inspection that ran Jul 3 – Jul 11, 2023. The investigators were Raquel Gonzalez Rivera and Saundrea A. Munroe. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194(a)(4) (1×) · 211.194(a)(1) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records are deficient in that they do not include a complete record of all…
- 02
Laboratory records do not include a description of the sample received for testing, the quantity of…
This inspection in context
Raquel Gonzalez Rivera
7 documents · 2013–2023
Cites 211.194(a) (laboratory records) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmLupin Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194(a)(4)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lupin Limited?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Lupin Limited?
Raquel Gonzalez Rivera and Saundrea A. Munroe are named on this Form 483, for the inspection of Jul 3 – Jul 11, 2023. Each investigator has a profile showing what they cite most.
When was Lupin Limited inspected by FDA?
The inspection ran Jul 3 – Jul 11, 2023, and the Form 483 is dated July 11, 2023.
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.