Form 483

Gaffney Foods, Inc. Form 483, 2016-10-06

FDA issued a Form 483 to Gaffney Foods, Inc. on 2016-10-06 with 9 public-safe observations.

483· Form 483 issuedFoods & Cosmetics9 observations

Gaffney Foods, Inc. · San Diego, United States · Issued October 6, 2016

Overview

  • 9 public-safe observations are available for this inspection.
  • 9 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 Oct 2016
21 CFR 110.20(b)(7)

Screening

Cited by Geoffrey M Leist, Sara J Dent Acosta

6 Oct 2016
21 CFR 110.35(d)(5)

Shown to be effective

Cited by Geoffrey M Leist, Sara J Dent Acosta

6 Oct 2016
21 CFR 110.37(b)(3)

As source of contamination

Cited by Geoffrey M Leist, Sara J Dent Acosta

6 Oct 2016
21 CFR 110.37(d)(2)

Good repair

Cited by Geoffrey M Leist, Sara J Dent Acosta

6 Oct 2016
21 CFR 123.6(c)(2)

Critical control points

Cited by Geoffrey M Leist, Sara J Dent Acosta

Inspected site

GFGaffney Foods, Inc.San Diego, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.37(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.6(d)Cited across public-safe Form 483 observations1x

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