Form 483

TWIN RIVER SOUTH, LLC Form 483, 2024-06-06

FDA issued a Form 483 to TWIN RIVER SOUTH, LLC on 2024-06-06 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

TWIN RIVER SOUTH, LLC · Portland, United States · Issued June 6, 2024

Overview

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

Inspectional observations

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

6 Jun 2024
21 CFR 1.504(a)

Hazard analysis written

Cited by John R Myung, Timothy S Williamson

6 Jun 2024
21 CFR 1.505(a)(2)

Evaluation - performance, risk

Cited by John R Myung, Timothy S Williamson

6 Jun 2024
21 CFR 1.506(e)(1)(i)(B)

Audit - food safety regulation, plan

Cited by John R Myung, Timothy S Williamson

Inspected site

TRTWIN RIVER SOUTH, LLCPortland, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.504(a)Cited across public-safe Form 483 observations1x
21 CFR 1.505(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.506(e)(1)(i)(B)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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