Cipla Limited
Form 483 issued June 21, 2024 · Verna, India
- Inspection
- Jun 10 – Jun 21, 2024
- Investigators
- Eileen A. Liu· Joseph A. Piechocki· Tamil Arasu
- Observations
- 6
- Pages
- 15
- FEI number
- 3004081307
In short: On June 21, 2024, FDA issued a Form 483 with 6 observations to Cipla Limited in Verna, India (FEI 3004081307) after an inspection that ran Jun 10 – Jun 21, 2024. The investigators were Eileen A. Liu, Joseph A. Piechocki and Tamil Arasu. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
There is a failure to thoroughly review the failure of a batch or any of its…
This inspection in context
Eileen A. Liu
41 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) 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 211.165(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cipla Limited?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Cipla Limited?
Eileen A. Liu, Joseph A. Piechocki and Tamil Arasu are named on this Form 483, for the inspection of Jun 10 – Jun 21, 2024. Each investigator has a profile showing what they cite most.
When was Cipla Limited inspected by FDA?
The inspection ran Jun 10 – Jun 21, 2024, and the Form 483 is dated June 21, 2024.
How do I get the full Form 483 for Cipla Limited?
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