Atlas

Form 483

Catalina Offshore Products, Inc Form 483, 2019-08-09

FDA issued a Form 483 to Catalina Offshore Products, Inc on 2019-08-09 with 9 public-safe observations.

483· Form 483 issuedFoods & Cosmetics9 observations

Catalina Offshore Products, Inc · San Diego, United States · Issued August 9, 2019

Overview

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

9 Aug 2019
21 CFR 123.6(b)

HACCP plan implementation

Cited by Sparky L Bartee

9 Aug 2019
21 CFR 123.6(b)

No HACCP plan

Cited by Sparky L Bartee

9 Aug 2019
21 CFR 123.6(c)(3)

Critical limits

Cited by Sparky L Bartee

9 Aug 2019
21 CFR 123.6(b)

HACCP plan implementation

Cited by Sparky L Bartee

9 Aug 2019
21 CFR 123.6(b)

HACCP plan implementation

Cited by Sparky L Bartee

Inspected site

COCatalina Offshore Products, IncSan Diego, United States

Inspection team

SLSparky L Bartee

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(b)Cited across public-safe Form 483 observations6x
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 9 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