Lupin Limited (Biotech Division)
Form 483 issued October 14, 2022 · Pune, India
- Inspection
- Oct 3 – Oct 14, 2022
- Investigators
- Cynthia Jim· Wayne Seifert· Yan Wang
- Observations
- 11
- Pages
- 10
- FEI number
- 3010977634
In short: On October 14, 2022, FDA issued a Form 483 with 11 observations to Lupin Limited (Biotech Division) in Pune, Maharashtra (FEI 3010977634) after an inspection that ran Oct 3 – Oct 14, 2022. The investigators were Cynthia Jim, Wayne Seifert, Yan Wang and Yongmin Liu.
What FDA observed
Preview: the opening words of each observation- 01
Observation 1: scanned text, readable in the full document.
This inspection in context
Cynthia Jim
20 documents · 2012–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
The firmLupin Limited (Biotech Division) history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Lupin Limited (Biotech Division)?
FDA listed 11 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Lupin Limited (Biotech Division)?
Cynthia Jim, Wayne Seifert, Yan Wang and Yongmin Liu are named on this Form 483, for the inspection of Oct 3 – Oct 14, 2022. Each investigator has a profile showing what they cite most.
When was Lupin Limited (Biotech Division) inspected by FDA?
The inspection ran Oct 3 – Oct 14, 2022, and the Form 483 is dated October 14, 2022.
How do I get the full Form 483 for Lupin Limited (Biotech Division)?
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.