Form 483

Finish Line Horse Products Inc. Form 483, 2022-09-16

FDA issued a Form 483 to Finish Line Horse Products Inc. on 2022-09-16 with 5 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds5 observations

Finish Line Horse Products Inc. · Bensenville, United States · Issued September 16, 2022

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

16 Sep 2022
21 CFR 211.125(a)

Strict control not exercised over labeling issued

Cited by Peng Zhou

16 Sep 2022
21 CFR 211.166(b)

Adequate number of batches on stability

Cited by Peng Zhou

16 Sep 2022
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Peng Zhou

16 Sep 2022
21 CFR 211.42(c)(2)

Rejected Material Area

Cited by Peng Zhou

16 Sep 2022
21 CFR 211.56(a)

Sanitation--buildings not clean, free of infestation

Cited by Peng Zhou

Inspected site

FLFinish Line Horse Products Inc.Bensenville, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(b)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 5 observations

The source PDF, 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