Atlas

Form 483

Stoney Marine International DBA Coleman Supply Company Form 483, 2014-02-21

FDA issued a Form 483 to Stoney Marine International DBA Coleman Supply Company on 2014-02-21 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Stoney Marine International DBA Coleman Supply Company · Charleston, United States · Issued February 21, 2014

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.

21 Feb 2014
21 CFR 110.20(b)(7)

Screening

Cited by Hristu B Chepa

21 Feb 2014
21 CFR 110.35(a)

Buildings/sanitary

Cited by Hristu B Chepa

21 Feb 2014
21 CFR 110.93

Storage/transportation of finished goods (contamination)

Cited by Hristu B Chepa

Inspected site

SMStoney Marine International DBA Coleman Supply CompanyCharleston, United States

Inspection team

HBHristu B Chepa

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.93Cited 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