Cipla Limited
Form 483 issued August 30, 2016 · Salcette, India
- Inspection
- Aug 22 – Aug 30, 2016
- Investigator
- Nicholas Violand
- Observations
- 1
- Pages
- 4
In short: On August 30, 2016, FDA issued a Form 483 with 1 observation to Cipla Limited in Salcette, Goa after an inspection that ran Aug 22 – Aug 30, 2016. The investigator was Nicholas Violand. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
This inspection in context
Nicholas Violand
17 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New Jersey.
The firmCipla Limited history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cipla Limited?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Cipla Limited?
Nicholas Violand is named on this Form 483, for the inspection of Aug 22 – Aug 30, 2016. Each investigator has a profile showing what they cite most.
When was Cipla Limited inspected by FDA?
The inspection ran Aug 22 – Aug 30, 2016, and the Form 483 is dated August 30, 2016.
How do I get the full Form 483 for Cipla 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.