Form 483

H & H Products Company Form 483, 2011-02-17

FDA issued a Form 483 to H & H Products Company on 2011-02-17 with 8 public-safe observations.

483· Form 483 issued8 observations

H & H Products Company · Orlando, United States · Issued February 17, 2011

Overview

  • 8 public-safe observations are available for this inspection.
  • 8 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.

17 Feb 2011
21 CFR 120.6(b)

Sanitation monitoring

Cited by Lindsay R Hatch, Stacey F Allard

17 Feb 2011
21 CFR 120.6(c)

SSOP records

Cited by Lindsay R Hatch, Stacey F Allard

17 Feb 2011
21 CFR 120.7(a)

No hazard analysis

Cited by Lindsay R Hatch, Stacey F Allard

17 Feb 2011
21 CFR 120.8(a)

HACCP plan not implemented

Cited by Lindsay R Hatch, Stacey F Allard

17 Feb 2011
21 CFR 120.8(b)(1)

HACCP plan - food hazards not listed

Cited by Lindsay R Hatch, Stacey F Allard

Inspected site

H&H & H Products CompanyOrlando, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 120.11(b)Cited across public-safe Form 483 observations1x
21 CFR 120.12(b)Cited across public-safe Form 483 observations1x
21 CFR 120.24(c)Cited across public-safe Form 483 observations1x
21 CFR 120.6(b)Cited across public-safe Form 483 observations1x
21 CFR 120.6(c)Cited across public-safe Form 483 observations1x
21 CFR 120.7(a)Cited across public-safe Form 483 observations1x
21 CFR 120.8(a)Cited across public-safe Form 483 observations1x
21 CFR 120.8(b)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 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