Lupin Limited Unit 1
Form 483 issued November 23, 2022 · Mandideep, India
- Inspection
- Nov 14 – Nov 23, 2022
- Investigators
- Rajiv R. Srivastava· Thomas J. Arista
- Observations
- 1
- Pages
- 14
- FEI number
- 3002807511
In short: On November 23, 2022, FDA issued a Form 483 with 1 observation to Lupin Limited Unit 1 in Mandideep, India (FEI 3002807511) after an inspection that ran Nov 14 – Nov 23, 2022. The investigators were Rajiv R. Srivastava and Thomas J. Arista.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure tw thoroughly review any unexplained distrepancy and the failure ofa batch or…
This inspection in context
Rajiv R. Srivastava
30 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmLupin Limited Unit 1 history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Lupin Limited Unit 1?
FDA listed 1 observation on this Form 483. The opening words of each observation are shown on this page.
Who inspected Lupin Limited Unit 1?
Rajiv R. Srivastava and Thomas J. Arista are named on this Form 483, for the inspection of Nov 14 – Nov 23, 2022. Each investigator has a profile showing what they cite most.
When was Lupin Limited Unit 1 inspected by FDA?
The inspection ran Nov 14 – Nov 23, 2022, and the Form 483 is dated November 23, 2022.
How do I get the full Form 483 for Lupin Limited Unit 1?
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.