Form 483

H & H Products Company Form 483, 2018-07-20

FDA issued a Form 483 to H & H Products Company on 2018-07-20 with 7 public-safe observations.

483· Form 483 issuedFoods & Cosmetics7 observations

H & H Products Company · Orlando, United States · Issued July 20, 2018

Overview

  • 7 public-safe observations are available for this inspection.
  • 7 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.

20 Jul 2018
21 CFR 114.80(b)

Code - required elements

Cited by Robert W Calais

20 Jul 2018
21 CFR 114.89

Process deviation

Cited by Robert W Calais

20 Jul 2018
21 CFR 117.35(a)

Sanitary Operations - Plant Maintenance

Cited by Robert W Calais

20 Jul 2018
21 CFR 120.24(c)

Process controls - not exempt, single facility

Cited by Robert W Calais

20 Jul 2018
21 CFR 117.35(c)

Pest Control

Cited by Robert W Calais

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 114.80(b)Cited across public-safe Form 483 observations1x
21 CFR 114.89Cited across public-safe Form 483 observations1x
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 117.35(c)Cited across public-safe Form 483 observations1x
21 CFR 120.24(a)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

Full 483 report

Get the verbatim text of all 7 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