Form 483

Pet Proteins LLC DBA Roam Pets Form 483, 2022-03-11

FDA issued a Form 483 to Pet Proteins LLC DBA Roam Pets on 2022-03-11 with 4 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds4 observations

Pet Proteins LLC DBA Roam Pets · Holmdel, United States · Issued March 11, 2022

Overview

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

11 Mar 2022
21 CFR 1.504(b)(1)

Hazard analysis biological, chemical, physical

Cited by Willy A Orantes

11 Mar 2022
21 CFR 1.505(a)(2)

Evaluation - performance, risk

Cited by Willy A Orantes

11 Mar 2022
21 CFR 1.505(b)

Supplier approval - document

Cited by Willy A Orantes

11 Mar 2022
21 CFR 1.506(b)

Supplier verification - establish written procedures

Cited by Willy A Orantes

Inspected site

PPPet Proteins LLC DBA Roam PetsHolmdel, 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(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.505(b)Cited across public-safe Form 483 observations1x
21 CFR 1.506(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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