Form 483

Pontiac Foods Form 483, 2019-04-19

FDA issued a Form 483 to Pontiac Foods on 2019-04-19 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Pontiac Foods · Elgin, United States · Issued April 19, 2019

Overview

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

19 Apr 2019
21 CFR 117.35(a)

Sanitary Operations - Plant Maintenance

Cited by Myckie M Jacobsen, Katelynn J Gulya, Katelynn J Rollins

19 Apr 2019
21 CFR 117.35(b)(2)

Toxic Chemicals - identified, held, stored

Cited by Myckie M Jacobsen, Katelynn J Gulya, Katelynn J Rollins

19 Apr 2019
21 CFR 117.37

Sanitary Facilities and Control

Cited by Myckie M Jacobsen, Katelynn J Gulya, Katelynn J Rollins

19 Apr 2019
21 CFR 117.80(b)(8)

Raw Materials - Allergen Identification

Cited by Myckie M Jacobsen, Katelynn J Gulya, Katelynn J Rollins

Inspected site

PFPontiac FoodsElgin, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 117.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 117.37Cited across public-safe Form 483 observations1x
21 CFR 117.80(b)(8)Cited across public-safe Form 483 observations1x

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