Lupin Limited (Unit II)
Form 483 issued December 4, 2018 · Mandideep, India
- Inspection
- Nov 26 – Dec 4, 2018
- Investigator
- Dipesh K. Shah
- Observations
- 4
- Pages
- 5
- FEI number
- 3007756473
In short: On December 4, 2018, FDA issued a Form 483 with 4 observations to Lupin Limited (Unit II) in Mandideep, Madhya Pradesh (FEI 3007756473) after an inspection that ran Nov 26 – Dec 4, 2018. The investigator was Dipesh K. Shah. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and Utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 02
Performance Qualification (PQ) of water treatment…
- 03
Quality Unit oversight is…
- 04
Restrictive controls to user access levels of computerized systems…
This inspection in context
Dipesh K. Shah
29 documents · 2006–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmLupin Limited (Unit II) history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lupin Limited (Unit II)?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Lupin Limited (Unit II)?
Dipesh K. Shah is named on this Form 483, for the inspection of Nov 26 – Dec 4, 2018. Each investigator has a profile showing what they cite most.
When was Lupin Limited (Unit II) inspected by FDA?
The inspection ran Nov 26 – Dec 4, 2018, and the Form 483 is dated December 4, 2018.
How do I get the full Form 483 for Lupin Limited (Unit II)?
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.