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Form 483

Wells Enterprises, Inc. Form 483, 2020-03-18

FDA issued a Form 483 to Wells Enterprises, Inc. on 2020-03-18 with 1 public-safe observation.

483· Form 483 issuedFoods & Cosmetics1 observation

Wells Enterprises, Inc. · Dunkirk, United States · Issued March 18, 2020

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

18 Mar 2020
21 CFR 117.145(a)

Sanitation Controls Monitoring Proced: Establish Implement

Cited by Elizabeth H Davis, Joel R Merriman, Christopher S Fields

Inspected site

WEWells Enterprises, Inc.Dunkirk, United States

Inspection team

EHElizabeth H Davis
JRJoel R Merriman
CSChristopher S Fields

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.145(a)Cited across public-safe Form 483 observations1x

Full 483 report

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The full inspection record, as Atlas holds it, 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