Atlas

Form 483

Jubilant Cadista Pharmaceuticals, Inc. Form 483, 2011-03-23

FDA issued a Form 483 to Jubilant Cadista Pharmaceuticals, Inc. on 2011-03-23 with 3 public-safe observations.

483· Form 483 issued3 observations

Jubilant Cadista Pharmaceuticals, Inc. · Salisbury, United States · Issued March 23, 2011

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

23 Mar 2011
21 CFR 211.165(f)

Failing drug products not rejected

Cited by Rachel C Harrington

23 Mar 2011
21 CFR 211.166(a)

Written program not followed

Cited by Rachel C Harrington

23 Mar 2011
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Rachel C Harrington

Inspected site

JCJubilant Cadista Pharmaceuticals, Inc.Salisbury, United States

Inspection team

RCRachel C Harrington

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.165(f)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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