Form 483

H & H Products Company Form 483, 2023-03-10

FDA issued a Form 483 to H & H Products Company on 2023-03-10 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

H & H Products Company · Orlando, United States · Issued March 10, 2023

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

10 Mar 2023
21 CFR 108.25(c)(2)

Process filing

Cited by Lissette Paiz

10 Mar 2023
21 CFR 114.10

Personnel

Cited by Lissette Paiz

10 Mar 2023
21 CFR 117.35(a)

Sanitary operations - Plant sanitation

Cited by Lissette Paiz

10 Mar 2023
21 CFR 120.24(a)

Process controls - HACCP plan - 5 log reduction

Cited by Lissette Paiz

10 Mar 2023
21 CFR 120.6(b)

Sanitation monitoring

Cited by Lissette Paiz

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 108.25(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 114.10Cited across public-safe Form 483 observations1x
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 120.24(a)Cited across public-safe Form 483 observations1x
21 CFR 120.6(b)Cited across public-safe Form 483 observations1x
21 CFR 120.8(b)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 observations

The full inspection record, as Atlas holds it, 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