Form 483

Rouge River Farms Inc Form 483, 2026-04-03

FDA issued a Form 483 to Rouge River Farms Inc on 2026-04-03 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

Rouge River Farms Inc · Clewiston, United States · Issued April 3, 2026

Overview

  • 8 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.

3 Apr 2026
21 CFR 117.135(a)(1)

Process preventive controls - Implement

Cited by Brittany C Smith

3 Apr 2026
21 CFR 117.135(a)(1)

Process preventive controls - Implement

Cited by Brittany C Smith

3 Apr 2026
21 CFR 117.135(c)(6)

Other Preventive Controls - Appropriate (Adequate)

Cited by Brittany C Smith

3 Apr 2026
21 CFR 117.135(c)(6)

Other Preventive Controls - Appropriate (Adequate)

Cited by Brittany C Smith

3 Apr 2026
21 CFR 117.35(a)

Sanitary operations - Plant maintenance

Cited by Brittany C Smith

Inspected site

RRRouge River Farms IncClewiston, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.135(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 117.135(c)(6)Cited across public-safe Form 483 observations2x
21 CFR 117.35(a)Cited across public-safe Form 483 observations2x
21 CFR 117.35(b)(1)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 8 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