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Form 483

Cipla Limited Form 483, 2016-08-30

FDA issued a Form 483 to Cipla Limited on 2016-08-30 with 12 public-safe observations.

483· Form 483 issuedHuman Drugs12 observations

Cipla Limited · Salcette, India · Issued August 30, 2016

Overview

  • 12 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

30 Aug 2016
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Nicholas A Violand

30 Aug 2016
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by Nicholas A Violand

30 Aug 2016
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by Nicholas A Violand

30 Aug 2016
21 CFR 211.63

Equipment Design, Size and Location

Cited by Nicholas A Violand

30 Aug 2016
21 CFR 314.81(b)(1)(ii)

Contamination, chemical or physical change, deterioration

Cited by Nicholas A Violand

Inspected site

CLCipla LimitedSalcette, India

Inspection team

NANicholas A Violand

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations3x
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.63Cited across public-safe Form 483 observations3x
21 CFR 314.81(b)(1)(ii)Cited across public-safe Form 483 observations3x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 12 observations

The source PDF and every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere