Form 483

New Generation Wellness Inc. Form 483, 2025-08-26

FDA issued a Form 483 to New Generation Wellness Inc. on 2025-08-26 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

New Generation Wellness Inc. · Colorado Springs, United States · Issued August 26, 2025

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

26 Aug 2025
21 CFR 111.320(b)

Examination, testing; scientifically valid

Cited by Oluwaseyi Ojinni

26 Aug 2025
21 CFR 111.70(b)

Specifications - components

Cited by Oluwaseyi Ojinni

26 Aug 2025
21 CFR 111.70(e)

Specifications - finished dietary supplement

Cited by Oluwaseyi Ojinni

Inspected site

NGNew Generation Wellness Inc.Colorado Springs, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.320(b)Cited across public-safe Form 483 observations1x
21 CFR 111.70(b)Cited across public-safe Form 483 observations1x
21 CFR 111.70(e)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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