Form 483

Home Style Foods, Inc. Form 483, 2018-06-04

FDA issued a Form 483 to Home Style Foods, Inc. on 2018-06-04 with 16 public-safe observations.

483· Form 483 issuedFoods & Cosmetics16 observations

Home Style Foods, Inc. · Hamtramck, United States · Issued June 4, 2018

Overview

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

Inspectional observations

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

4 Jun 2018
21 CFR 117.310

Food Safety Plan - Signing

Cited by Alexandra A Carrico, Linda S Jozefiak, Michelle L Jones, Rasha Bamieh

4 Jun 2018
21 CFR 123.11(b)

Sanitation monitoring

Cited by Alexandra A Carrico, Linda S Jozefiak, Michelle L Jones, Rasha Bamieh

4 Jun 2018
21 CFR 123.6(b)

HACCP plan implementation

Cited by Alexandra A Carrico, Linda S Jozefiak, Michelle L Jones, Rasha Bamieh

4 Jun 2018
21 CFR 123.8(a)(1)

Reassessment of HACCP plan

Cited by Alexandra A Carrico, Linda S Jozefiak, Michelle L Jones, Rasha Bamieh

4 Jun 2018
21 CFR 123.8(a)(2)(ii)

Calibration - adequacy

Cited by Alexandra A Carrico, Linda S Jozefiak, Michelle L Jones, Rasha Bamieh

Inspected site

HSHome Style Foods, Inc.Hamtramck, United States

Inspection team

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 117.150(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.145(b)Cited across public-safe Form 483 observations1x
21 CFR 117.145(c)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.165(b)Cited across public-safe Form 483 observations1x
21 CFR 117.310Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations1x
21 CFR 123.7(d)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)(ii)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 16 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