Atlas

Form 483

Grindstone Neck of Maine, LLC Form 483, 2017-09-01

FDA issued a Form 483 to Grindstone Neck of Maine, LLC on 2017-09-01 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Grindstone Neck of Maine, LLC · Winter Harbor, United States · Issued September 1, 2017

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.

1 Sep 2017
21 CFR 123.6(c)(2)

Critical control points

Cited by Bradford L Swanson

1 Sep 2017
21 CFR 123.6(c)(3)

Critical limits

Cited by Bradford L Swanson

1 Sep 2017
21 CFR 123.6(c)(6)

Verification procedures - none/frequency

Cited by Bradford L Swanson

Inspected site

GNGrindstone Neck of Maine, LLCWinter Harbor, United States

Inspection team

BLBradford L Swanson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited 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