Form 483

Kingdomway Health Sciences LLC Form 483, 2025-12-03

FDA issued a Form 483 to Kingdomway Health Sciences LLC on 2025-12-03 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Kingdomway Health Sciences LLC · Casa Grande, United States · Issued December 3, 2025

Overview

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

3 Dec 2025
21 CFR 211.165(b)

Microbiological testing

Cited by Mickell Smith

3 Dec 2025
21 CFR 211.84(d)(1)

Identity Testing of Each Component

Cited by Mickell Smith

Inspected site

KHKingdomway Health Sciences LLCCasa Grande, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.165(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(1)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 2 observations

The source PDF, 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