Cipla Ltmited
Form 483 issued November 13, 2019 · Raigad, India
- Inspection
- Nov 4 – Nov 13, 2019
- Investigator
- Taichun Qin
- Observations
- 4
- Pages
- 4
- FEI number
- 3002806710
In short: On November 13, 2019, FDA issued a Form 483 with 4 observations to Cipla Ltmited in Raigad, Maharashtra (FEI 3002806710) after an inspection that ran Nov 4 – Nov 13, 2019. The investigator was Taichun Qin. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
4 of 4 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (3×)
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 any unexplained discrepancy and the failure of a batch…
- 02
Failure to investigate finished API batches not meeting the predetermined established criteria or with out of…
- 03
The quality control unit lacks authority to review production records to assure that no errors have…
- 04
Employees engaged in the manufacture and processing of a drug product lack the training and experience…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmCipla Ltmited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cipla Ltmited?
FDA listed 4 observations 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 Ltmited?
Taichun Qin is named on this Form 483, for the inspection of Nov 4 – Nov 13, 2019. Each investigator has a profile showing what they cite most.
When was Cipla Ltmited inspected by FDA?
The inspection ran Nov 4 – Nov 13, 2019, and the Form 483 is dated November 13, 2019.
How do I get the full Form 483 for Cipla Ltmited?
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.