Form 483

Sebastian Joe's Corporation Form 483, 2015-07-09

FDA issued a Form 483 to Sebastian Joe's Corporation on 2015-07-09 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Sebastian Joe's Corporation · Minneapolis, United States · Issued July 9, 2015

Overview

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

Inspectional observations

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

9 Jul 2015
21 CFR 110.10(b)(5)

Glove condition

Cited by Kibily D Dembele, Karen M Labounty

9 Jul 2015
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Kibily D Dembele, Karen M Labounty

9 Jul 2015
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Kibily D Dembele, Karen M Labounty

9 Jul 2015
21 CFR 110.80

Reasonable precautions

Cited by Kibily D Dembele, Karen M Labounty

9 Jul 2015
21 CFR 110.80(a)(1)

Storage

Cited by Kibily D Dembele, Karen M Labounty

Inspected site

SJSebastian Joe's CorporationMinneapolis, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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