Form 483

Jowdy Industries, Inc. Form 483, 2011-03-11

FDA issued a Form 483 to Jowdy Industries, Inc. on 2011-03-11 with 12 public-safe observations.

483· Form 483 issued12 observations

Jowdy Industries, Inc. · West Palm Beach, United States · Issued March 11, 2011

Overview

  • 12 public-safe observations are available for this inspection.
  • 11 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.

11 Mar 2011
21 CFR 110.40(c)

Non food-contact equipment in processing area

Cited by Marc Balzarini

11 Mar 2011
21 CFR 110.40(f)

Q.C. instrument accuracy, maintenance

Cited by Marc Balzarini

11 Mar 2011
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Marc Balzarini

11 Mar 2011
21 CFR 123.6(b)

HACCP plan implementation

Cited by Marc Balzarini

11 Mar 2011
21 CFR 123.6(b)

No HACCP plan

Cited by Marc Balzarini

Inspected site

JIJowdy Industries, Inc.West Palm Beach, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(b)Cited across public-safe Form 483 observations2x
21 CFR 110.40(c)Cited across public-safe Form 483 observations1x
21 CFR 110.40(f)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.12(a)(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)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(7)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.9(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 12 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