Form 483

PURE FRESH LLC Form 483, 2024-05-16

FDA issued a Form 483 to PURE FRESH LLC on 2024-05-16 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

PURE FRESH LLC · Pompano Beach, United States · Issued May 16, 2024

Overview

  • 4 public-safe observations are available for this inspection.
  • 3 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 May 2024
21 CFR 1.504(d)

Document review entity's hazard analysis

Cited by Stanley Nelson

16 May 2024
21 CFR 1.505(c)(1)

Continue to import, change activities

Cited by Stanley Nelson

16 May 2024
21 CFR 1.505(c)(1)

Revaluate - new information

Cited by Stanley Nelson

16 May 2024
21 CFR 1.508(b)

Investigate

Cited by Stanley Nelson

Inspected site

PFPURE FRESH LLCPompano Beach, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.505(c)(1)Cited across public-safe Form 483 observations2x
21 CFR 1.504(d)Cited across public-safe Form 483 observations1x
21 CFR 1.508(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