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Form 483

kdc/one Chatsworth, Inc. Form 483, 2009-06-25

FDA issued a Form 483 to kdc/one Chatsworth, Inc. on 2009-06-25 with 4 public-safe observations.

483· Form 483 issued4 observations

kdc/one Chatsworth, Inc. · Chatsworth, United States · Issued June 25, 2009

Overview

  • 4 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.

25 Jun 2009
21 CFR 211.100(a)

Approval and review of procedures

Cited by Joey V Quitania

25 Jun 2009
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by Joey V Quitania

25 Jun 2009
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by Joey V Quitania

25 Jun 2009
21 CFR 211.198(a)

Procedures to be written and followed

Cited by Joey V Quitania

Inspected site

KCkdc/one Chatsworth, Inc.Chatsworth, United States

Inspection team

JVJoey V Quitania

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 4 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