Cipla Limited
Form 483 issued January 25, 2018 · Salcette, India
- Inspection
- Jan 22 – Jan 25, 2018
- Investigator
- Cheryl Clausen
- Observations
- 1
- Pages
- 8
- FEI number
- 3004081307
In short: On January 25, 2018, FDA issued a Form 483 with 1 observation to Cipla Limited in Salcette, Goa (FEI 3004081307) after an inspection that ran Jan 22 – Jan 25, 2018. The investigator was Cheryl Clausen. 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
There is a failure to thoroughly review the failure of a batch or any of its…
This inspection in context
Cheryl Clausen
18 documents · 2016–2020
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
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?
Cheryl Clausen is named on this Form 483, for the inspection of Jan 22 – Jan 25, 2018. Each investigator has a profile showing what they cite most.
When was Cipla Limited inspected by FDA?
The inspection ran Jan 22 – Jan 25, 2018, and the Form 483 is dated January 25, 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.