Form 483

kdc/one Chatsworth, Inc. Form 483, 2010-05-14

FDA issued a Form 483 to kdc/one Chatsworth, Inc. on 2010-05-14 with 3 public-safe observations.

483· Form 483 issued3 observations

kdc/one Chatsworth, Inc. · Chatsworth, United States · Issued May 14, 2010

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.

14 May 2010
21 CFR 211.25(a)

Training , Education , Experience overall

Cited by Sonia R Peterson

14 May 2010
21 CFR 211.67(c)

Cleaning/maintenance records not kept

Cited by Sonia R Peterson

14 May 2010
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Sonia R Peterson

Inspected site

KCkdc/one Chatsworth, Inc.Chatsworth, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(c)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 3 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