Form 483

U.B.C. Food Distributors INC. Form 483, 2023-06-07

FDA issued a Form 483 to U.B.C. Food Distributors INC. on 2023-06-07 with 7 public-safe observations.

483· Form 483 issuedFoods & Cosmetics7 observations

U.B.C. Food Distributors INC. · Dearborn, United States · Issued June 7, 2023

Overview

  • 7 public-safe observations are available for this inspection.
  • 7 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.

7 Jun 2023
21 CFR 1.504(b)(1)

Hazard analysis biological, chemical, physical

Cited by Kathleen M Adams, Brian E Beattie

7 Jun 2023
21 CFR 1.505(b)

Supplier approval - document

Cited by Kathleen M Adams, Brian E Beattie

7 Jun 2023
21 CFR 1.505(c)(2)

Reevaluate - 3 years

Cited by Kathleen M Adams, Brian E Beattie

7 Jun 2023
21 CFR 1.506(a)(1)

Approved supplier procedures - follow, document use

Cited by Kathleen M Adams, Brian E Beattie

7 Jun 2023
21 CFR 1.506(d)(1)(i)

Verification activity frequency

Cited by Kathleen M Adams, Brian E Beattie

Inspected site

UFU.B.C. Food Distributors INC.Dearborn, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.504(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.505(b)Cited across public-safe Form 483 observations1x
21 CFR 1.505(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.506(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.506(d)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 1.506(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.506(e)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 observations

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