FDA Intel

Cipla Limited

Form 483 issued August 26, 2022 · Verna, Salcette, Goa, India

Inspection
Aug 16 – Aug 26, 2022
Investigators
Jonah S. Ufferfilge· Justin A. Boyd· Teresa I. Navas
Observations
6
Pages
11
FEI number
3004081307

In short: On August 26, 2022, FDA issued a Form 483 with 6 observations to Cipla Limited in Verna, Salcette, Goa, Salcette (FEI 3004081307) after an inspection that ran Aug 16 – Aug 26, 2022. The investigators were Jonah S. Ufferfilge, Justin A. Boyd and Teresa I. Navas. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

4 of 6 observations on this 483 concern facilities & equipment.

Facilities & equipment4
Production1
Quality system1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.42(c)(10)(iv)

    Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. -H•l 1. The environmental…

  2. 02
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…

  3. 03
    21 CFR 211.42(c)(10)(v)

    Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the…

  4. 04
    21 CFR 211.68(b)

    Appropriate controls are not exercised over computers or related systems to assure that changes in master…

2 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Jonah S. Ufferfilge

17 documents · 2019–2023

Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Connecticut.

The firm

Cipla Limited history

All 9 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.42(c)(10)(iv)

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, production and quality system. 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?

Jonah S. Ufferfilge, Justin A. Boyd and Teresa I. Navas are named on this Form 483, for the inspection of Aug 16 – Aug 26, 2022. Each investigator has a profile showing what they cite most.

When was Cipla Limited inspected by FDA?

The inspection ran Aug 16 – Aug 26, 2022, and the Form 483 is dated August 26, 2022.

How do I get the full Form 483 for Cipla Limited?

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