Form 483

Stoney Marine International DBA Coleman Supply Company Form 483, 2019-05-21

FDA issued a Form 483 to Stoney Marine International DBA Coleman Supply Company on 2019-05-21 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

Stoney Marine International DBA Coleman Supply Company · Charleston, United States · Issued May 21, 2019

Overview

  • 8 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

21 May 2019
21 CFR 117.35(a)

Sanitary Operations - Plant Maintenance

Cited by Myckie M Jacobsen, Shekita T Maxwell, Stanley Nelson

21 May 2019
21 CFR 117.35(c)

Pest Control

Cited by Myckie M Jacobsen, Shekita T Maxwell, Stanley Nelson

21 May 2019
21 CFR 117.93

Storage and Transportation

Cited by Myckie M Jacobsen, Shekita T Maxwell, Stanley Nelson

21 May 2019
21 CFR 123.6(b)

No HACCP plan

Cited by Myckie M Jacobsen, Shekita T Maxwell, Stanley Nelson

21 May 2019
21 CFR 117.35(a)

Sanitary Operations - Plant Maintenance

Cited by Myckie M Jacobsen, Shekita T Maxwell, Stanley Nelson

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.35(a)Cited across public-safe Form 483 observations2x
21 CFR 117.35(c)Cited across public-safe Form 483 observations2x
21 CFR 117.93Cited across public-safe Form 483 observations2x
21 CFR 123.6(b)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 8 observations

The full inspection record, as Atlas holds it, 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