Form 483

Maine Homestead Inc. Form 483, 2013-09-25

FDA issued a Form 483 to Maine Homestead Inc. on 2013-09-25 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Maine Homestead Inc. · Lyman, United States · Issued September 25, 2013

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

25 Sep 2013
21 CFR 108.25(c)(2)

Process filing

Cited by Bradford L Swanson

25 Sep 2013
21 CFR 108.25(e)

Recall procedures

Cited by Bradford L Swanson

25 Sep 2013
21 CFR 108.25(f)

Approved school

Cited by Bradford L Swanson

25 Sep 2013
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Bradford L Swanson

25 Sep 2013
21 CFR 114.100(a)

Raw materials, packaging, finished product

Cited by Bradford L Swanson

Inspected site

MHMaine Homestead Inc.Lyman, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 108.25(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 108.25(e)Cited across public-safe Form 483 observations1x
21 CFR 108.25(f)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 114.100(a)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