Atlas

Form 483

Custom Seasonings, Inc. Form 483, 2019-05-02

FDA issued a Form 483 to Custom Seasonings, Inc. on 2019-05-02 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Custom Seasonings, Inc. · Gloucester, United States · Issued May 2, 2019

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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 May 2019
21 CFR 117.165(b)

Process Controls Verif Procedures: Establish Implement

Cited by Alysia M Salonia

2 May 2019
21 CFR 117.80(c)

Manufacturing, Processing, Packing, Holding - Controls

Cited by Alysia M Salonia

Inspected site

CSCustom Seasonings, Inc.Gloucester, United States

Inspection team

AMAlysia M Salonia

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.165(b)Cited across public-safe Form 483 observations1x
21 CFR 117.80(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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