Atlas

Form 483

Herbally Yours, Inc. Form 483, 2023-03-22

FDA issued a Form 483 to Herbally Yours, Inc. on 2023-03-22 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Herbally Yours, Inc. · Gilbert, United States · Issued March 22, 2023

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

22 Mar 2023
21 CFR 111.123(a)(6)

Quality control operations - in-process specifications

Cited by Robert P Neligan, Eric R Holm

22 Mar 2023
21 CFR 111.465(b)

Retain reserve samples - 1 year, 2 years

Cited by Robert P Neligan, Eric R Holm

Inspected site

HYHerbally Yours, Inc.Gilbert, United States

Inspection team

RPRobert P Neligan
EREric R Holm

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.123(a)(6)Cited across public-safe Form 483 observations1x
21 CFR 111.465(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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