Cipla Limited
Form 483 issued February 6, 2023 · Pithampur, India
- Inspection
- Feb 6, 2023
- Investigators
- Jose E. Melendez· Saleem A. Akhtar
- Observations
- 8
- Pages
- 23
- FEI number
- 3008581988
In short: On February 6, 2023, FDA issued a Form 483 with 8 observations to Cipla Limited in Pithampur, India (FEI 3008581988) after an inspection that ran Feb 6, 2023. The investigators were Jose E. Melendez and Saleem A. Akhtar. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
Quality system and facilities & equipment account for 5 of 8 observations.
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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. -H•J A. The rt')…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cipla Limited?
FDA listed 8 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Cipla Limited?
Jose E. Melendez and Saleem A. Akhtar are named on this Form 483, for the inspection of Feb 6, 2023. Each investigator has a profile showing what they cite most.
When was Cipla Limited inspected by FDA?
The inspection ran Feb 6, 2023, and the Form 483 is dated February 6, 2023.
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.