Atlas

Form 483

The Original Bradford Soap Works, Inc. Form 483, 2012-05-23

FDA issued a Form 483 to The Original Bradford Soap Works, Inc. on 2012-05-23 with 4 public-safe observations.

483· Form 483 issued4 observations

The Original Bradford Soap Works, Inc. · West Warwick, United States · Issued May 23, 2012

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.

23 May 2012
21 CFR 211.84(b)

Representative Samples Criteria

Cited by Stacey S Degarmo

23 May 2012
21 CFR 211.100(b)

Procedure Deviations Recorded and Justified

Cited by Stacey S Degarmo

23 May 2012
21 CFR 211.115(a)

Reprocessing procedures lack steps to be taken

Cited by Stacey S Degarmo

23 May 2012
21 CFR 211.166(a)

Written program not followed

Cited by Stacey S Degarmo

Inspected site

TOThe Original Bradford Soap Works, Inc.West Warwick, United States

Inspection team

SSStacey S Degarmo

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.115(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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