Form 483

H & H Products Company Form 483, 2012-05-08

FDA issued a Form 483 to H & H Products Company on 2012-05-08 with 4 public-safe observations.

483· Form 483 issued4 observations

H & H Products Company · Orlando, United States · Issued May 8, 2012

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

8 May 2012
21 CFR 120.6(b)

Sanitation monitoring

Cited by Lisa A Warner

8 May 2012
21 CFR 120.8(a)

HACCP plan not implemented

Cited by Lisa A Warner

8 May 2012
21 CFR 120.8(b)(6)

HACCP plan - verify procedures / frequency - none listed

Cited by Lisa A Warner

8 May 2012
21 CFR 120.12(c)

Records - signed/dated

Cited by Lisa A Warner

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 120.12(c)Cited across public-safe Form 483 observations1x
21 CFR 120.6(b)Cited across public-safe Form 483 observations1x
21 CFR 120.8(a)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 4 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