Form 483

Ayush Herbs Inc. Form 483, 2021-04-19

FDA issued a Form 483 to Ayush Herbs Inc. on 2021-04-19 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

Ayush Herbs Inc. · Redmond, United States · Issued April 19, 2021

Overview

  • 8 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.

19 Apr 2021
21 CFR 111.103

Written procedures - quality control operations

Cited by Lisa A Bowden

19 Apr 2021
21 CFR 111.103

Written procedures - quality control operations

Cited by Lisa A Bowden

19 Apr 2021
21 CFR 111.113(c)

Document - material review, disposition

Cited by Lisa A Bowden

19 Apr 2021
21 CFR 111.113(c)

Document - material review, disposition

Cited by Lisa A Bowden

19 Apr 2021
21 CFR 111.55

Production, process controls - implement

Cited by Lisa A Bowden

Inspected site

AHAyush Herbs Inc.Redmond, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.103Cited across public-safe Form 483 observations2x
21 CFR 111.113(c)Cited across public-safe Form 483 observations2x
21 CFR 111.55Cited across public-safe Form 483 observations2x
21 CFR 111.70(e)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 8 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