Atlas

Form 483

Cipla Limited Form 483, 2011-12-01

FDA issued a Form 483 to Cipla Limited on 2011-12-01 with 2 public-safe observations.

483· Form 483 issued2 observations

Cipla Limited · Kurkumbh Village, Dist. Pune, India · Issued December 1, 2011

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

1 Dec 2011
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Michael A Charles

1 Dec 2011
21 CFR 211.186(b)(9)

Complete instructions, procedures, specifications et. al.

Cited by Michael A Charles

Inspected site

CLCipla LimitedKurkumbh Village, Dist. Pune, India

Inspection team

MAMichael A Charles

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

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