Lupin Limited Block 21, Village Dabhasa; Taluka: Padra
Form 483 issued July 6, 2016 · District Vadodara, India
- Inspection
- Jun 27 – Jul 6, 2016
- Investigators
- Jose Lopez Rubet· Roger F. Zabinski
- Observations
- 1
- Pages
- 2
- FEI number
- 3005906909
In short: On July 6, 2016, FDA issued a Form 483 with 1 observation to Lupin Limited Block 21, Village Dabhasa; Taluka: Padra in District Vadodara, India (FEI 3005906909) after an inspection that ran Jun 27 – Jul 6, 2016. The investigators were Jose Lopez Rubet and Roger F. Zabinski. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.56 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm failed to validate disinfectant and sanitization procedures used in the clean controlled manufacturing areas…
This inspection in context
Jose Lopez Rubet
5 documents · 2015–2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmLupin Limited Block 21, Village Dabhasa; Taluka: Padra history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.56
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lupin Limited Block 21, Village Dabhasa; Taluka: Padra?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
Who inspected Lupin Limited Block 21, Village Dabhasa; Taluka: Padra?
Jose Lopez Rubet and Roger F. Zabinski are named on this Form 483, for the inspection of Jun 27 – Jul 6, 2016. Each investigator has a profile showing what they cite most.
When was Lupin Limited Block 21, Village Dabhasa; Taluka: Padra inspected by FDA?
The inspection ran Jun 27 – Jul 6, 2016, and the Form 483 is dated July 6, 2016.
How do I get the full Form 483 for Lupin Limited Block 21, Village Dabhasa; Taluka: Padra?
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.