Form 483

Maine's Own Treats, Inc. Form 483, 2017-08-02

FDA issued a Form 483 to Maine's Own Treats, Inc. on 2017-08-02 with 11 public-safe observations.

483· Form 483 issuedFoods & Cosmetics11 observations

Maine's Own Treats, Inc. · Trenton, United States · Issued August 2, 2017

Overview

  • 11 public-safe observations are available for this inspection.
  • 10 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.

2 Aug 2017
21 CFR 110.10(b)(6)

Failure to wear

Cited by Clinton V Giustra

2 Aug 2017
21 CFR 110.20(a)(1)

Harborage areas

Cited by Clinton V Giustra

2 Aug 2017
21 CFR 110.20(b)(1)

Sufficient space

Cited by Clinton V Giustra

2 Aug 2017
21 CFR 110.20(b)(7)

Screening

Cited by Clinton V Giustra

2 Aug 2017
21 CFR 110.35(a)

Buildings/sanitary

Cited by Clinton V Giustra

Inspected site

MOMaine's Own Treats, Inc.Trenton, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)Cited 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