Cipla Limited
Form 483 issued September 28, 2018 · Verna, India
- Inspection
- Sep 24 – Sep 28, 2018
- Investigators
- Nicole E. Knowlton· Pei-L Chu· Rebecca E. Dombrowski
- Observations
- 2
- Pages
- 1
- FEI number
- 3004081307
In short: On September 28, 2018, FDA issued a Form 483 with 2 observations to Cipla Limited in Verna, India (FEI 3004081307) after an inspection that ran Sep 24 – Sep 28, 2018. The investigators were Nicole E. Knowlton, Pei-L Chu and Rebecca E. Dombrowski. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.186 (master production and control records).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.186 (1×) · 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
The batch production and control records are deficient in that they do not include documentation of…
- 02
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
Nicole E. Knowlton
36 documents · 2013–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Florida.
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 211.186
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cipla Limited?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.186 (master production and control records). The opening words of each observation are shown on this page.
Who inspected Cipla Limited?
Nicole E. Knowlton, Pei-L Chu and Rebecca E. Dombrowski are named on this Form 483, for the inspection of Sep 24 – Sep 28, 2018. Each investigator has a profile showing what they cite most.
When was Cipla Limited inspected by FDA?
The inspection ran Sep 24 – Sep 28, 2018, and the Form 483 is dated September 28, 2018.
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.