Atlas

Form 483

Tropicana Manufacturing Company, Inc. Form 483, 2013-02-08

FDA issued a Form 483 to Tropicana Manufacturing Company, Inc. on 2013-02-08 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Tropicana Manufacturing Company, Inc. · City Of Industry, United States · Issued February 8, 2013

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

8 Feb 2013
21 CFR 120.8(b)(6)

HACCP plan - verify procedures / frequency - none listed

Cited by James P Stallings, Angela Shepas

8 Feb 2013
21 CFR 120.12(e)

Records - review and copying

Cited by James P Stallings, Angela Shepas

Inspected site

TMTropicana Manufacturing Company, Inc.City Of Industry, United States

Inspection team

JPJames P Stallings
ASAngela Shepas

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 120.12(e)Cited across public-safe Form 483 observations1x
21 CFR 120.8(b)(6)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

Every observation in full, 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