Atlas

Form 483

Wells Enterprises, Inc. Form 483, 2019-06-26

FDA issued a Form 483 to Wells Enterprises, Inc. on 2019-06-26 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Wells Enterprises, Inc. · Dunkirk, United States · Issued June 26, 2019

Overview

  • 3 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

26 Jun 2019
21 CFR 117.145(a)

Process Controls Monitoring Procedures: Establish Implement

Cited by Wendy M Stone, Elizabeth H Davis, Kyle J Spencer

26 Jun 2019
21 CFR 117.145(a)

Sanitation Controls Monitoring Proced: Establish Implement

Cited by Wendy M Stone, Elizabeth H Davis, Kyle J Spencer

26 Jun 2019
21 CFR 117.415(a)(2)

Supply-Chain Appropriate Verification Activities

Cited by Wendy M Stone, Elizabeth H Davis, Kyle J Spencer

Inspected site

WEWells Enterprises, Inc.Dunkirk, United States

Inspection team

WMWendy M Stone
EHElizabeth H Davis
KJKyle J Spencer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.145(a)Cited across public-safe Form 483 observations2x
21 CFR 117.415(a)(2)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