Form 483

Henry's United, Llc Form 483, 2026-01-08

FDA issued a Form 483 to Henry's United, Llc on 2026-01-08 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Henry's United, Llc · New Brunswick, United States · Issued January 8, 2026

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 Jan 2026
21 CFR 1.502(a)

Develop FSVP

Cited by Colleen Kim

8 Jan 2026
21 CFR 1.505(b)

Supplier approval - document

Cited by Colleen Kim

8 Jan 2026
21 CFR 1.506(b)

Supplier verification - follow written procedures

Cited by Colleen Kim

8 Jan 2026
21 CFR 1.506(e)(1)

Verification activity before import, periodically

Cited by Colleen Kim

Inspected site

HUHenry's United, LlcNew Brunswick, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.502(a)Cited across public-safe Form 483 observations1x
21 CFR 1.505(b)Cited across public-safe Form 483 observations1x
21 CFR 1.506(b)Cited across public-safe Form 483 observations1x
21 CFR 1.506(e)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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