Cipla Limited
Form 483 issued September 27, 2019 · Vasco Da Gama, India
- Inspection
- Sep 16 – Sep 27, 2019
- Investigators
- June P. Page· Rajiv R. Srivastava· Thomas J. Arista
- Observations
- 10
- Pages
- 38
- FEI number
- 3004081307
In short: On September 27, 2019, FDA issued a Form 483 with 10 observations to Cipla Limited in Vasco Da Gama, Goa (FEI 3004081307) after an inspection that ran Sep 16 – Sep 27, 2019. The investigators were June P. Page, Rajiv R. Srivastava and Thomas J. Arista. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
6 of 10 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 02
Equipment for adequate control over air pressure, micro-organisms and dust is not provided when appropriate for…
- 03
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 04
Buildings used in the manufacture, processing, packing, or holding of a dm g product do not…
This inspection in context
June P. Page
30 documents · 2015–2025
Cites 211.42 (design and construction features) 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cipla Limited?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production 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?
June P. Page, Rajiv R. Srivastava and Thomas J. Arista are named on this Form 483, for the inspection of Sep 16 – Sep 27, 2019. Each investigator has a profile showing what they cite most.
When was Cipla Limited inspected by FDA?
The inspection ran Sep 16 – Sep 27, 2019, and the Form 483 is dated September 27, 2019.
How do I get the full Form 483 for Cipla Limited?
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