Atlas

Form 483

The Coastal Companies DBA Hearn Kirkwood Form 483, 2019-09-26

FDA issued a Form 483 to The Coastal Companies DBA Hearn Kirkwood on 2019-09-26 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

The Coastal Companies DBA Hearn Kirkwood · Jessup, United States · Issued September 26, 2019

Overview

  • 4 public-safe observations are available for this inspection.
  • 2 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.

26 Sep 2019
21 CFR 117.35(b)(2)

Toxic Chemicals - identified, held, stored

Cited by Cornelius Brown, Angela L Hatzenbuhler

26 Sep 2019
21 CFR 117.35(b)(2)

Toxic Chemicals - identified, held, stored

Cited by Cornelius Brown, Angela L Hatzenbuhler

26 Sep 2019
21 CFR 117.80(c)

Manufacturing, Processing, Packing, Holding - Controls

Cited by Cornelius Brown, Angela L Hatzenbuhler

26 Sep 2019
21 CFR 117.80(c)

Manufacturing, Processing, Packing, Holding - Controls

Cited by Cornelius Brown, Angela L Hatzenbuhler

Inspected site

TCThe Coastal Companies DBA Hearn KirkwoodJessup, United States

Inspection team

CBCornelius Brown
ALAngela L Hatzenbuhler

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.35(b)(2)Cited across public-safe Form 483 observations2x
21 CFR 117.80(c)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 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