LUPIN LIMITED
Form 483 issued August 19, 2022 · Ankleshwar, India
- Inspection
- Aug 16 – Aug 19, 2022
- Investigator
- Alan P. Kurtzberg
- Observations
- 1
- Pages
- 1
- FEI number
- 3002807510
In short: On August 19, 2022, FDA issued a Form 483 with 1 observation to LUPIN LIMITED in Ankleshwar, Gujarat (FEI 3002807510) after an inspection that ran Aug 16 – Aug 19, 2022. The investigator was Alan P. Kurtzberg. Most observations concern production; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.188 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Batch production records do not include complete information relating to the…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
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 211.188
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 production. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected LUPIN LIMITED?
Alan P. Kurtzberg is named on this Form 483, for the inspection of Aug 16 – Aug 19, 2022. Each investigator has a profile showing what they cite most.
When was LUPIN LIMITED inspected by FDA?
The inspection ran Aug 16 – Aug 19, 2022, and the Form 483 is dated August 19, 2022.
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.