Cipla Limited
Form 483 issued July 1, 2022 · Indore SEZ, Pithampur, India
- Inspection
- Jun 27 – Jul 1, 2022
- Investigator
- Dipesh K. Shah
- Observations
- 2
- Pages
- 2
- FEI number
- 3008581988
In short: On July 1, 2022, FDA issued a Form 483 with 2 observations to Cipla Limited in Indore SEZ, Pithampur, India (FEI 3008581988) after an inspection that ran Jun 27 – Jul 1, 2022. The investigator was Dipesh K. Shah. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 02
Samples taken of drug products for determination of conformance to written specifications…
This inspection in context
Dipesh K. Shah
29 documents · 2006–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmCipla Limited history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
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 facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Cipla Limited?
Dipesh K. Shah is named on this Form 483, for the inspection of Jun 27 – Jul 1, 2022. Each investigator has a profile showing what they cite most.
When was Cipla Limited inspected by FDA?
The inspection ran Jun 27 – Jul 1, 2022, and the Form 483 is dated July 1, 2022.
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.