Form 483

3CPM Company, Inc. Form 483, 2009-11-06

FDA issued a Form 483 to 3CPM Company, Inc. on 2009-11-06 with 11 public-safe observations.

483· Form 483 issued11 observations

3CPM Company, Inc. · Towson, United States · Issued November 6, 2009

Overview

  • 11 public-safe observations are available for this inspection.
  • 11 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.

6 Nov 2009
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Merideth K Rose

6 Nov 2009
21 CFR 820.20(a)

Management ensuring quality policy is understood

Cited by Merideth K Rose

6 Nov 2009
21 CFR 820.30(a)

Design control - no procedures

Cited by Merideth K Rose

6 Nov 2009
21 CFR 820.40

Lack of procedures, or not maintained

Cited by Merideth K Rose

6 Nov 2009
21 CFR 820.50(a)

Evaluation of suppliers, contractors, etc., requirements

Cited by Merideth K Rose

Inspected site

3C3CPM Company, Inc.Towson, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.160(b)Cited across public-safe Form 483 observations1x
21 CFR 820.181(a)Cited across public-safe Form 483 observations1x
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.184(f)Cited across public-safe Form 483 observations1x
21 CFR 820.20(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(a)Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)Cited across public-safe Form 483 observations1x
21 CFR 820.86Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 11 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