Atlas

FDA-Inspected Site

New Generation Wellness Inc.

14 FDA inspections are on record for New Generation Wellness Inc. in Colorado Springs, United States.

483· Form 483 issued

Colorado Springs, United States · Last updated July 9, 2026

Overview

  • 14 FDA inspections are on record.
  • 8 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-08-26.

At a glance

Inspections

14

Form 483s

8

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
13 Aug 2025 – 26 Aug 2025Foods & Cosmetics483View 483 →
11 Jan 2021Human DrugsClean
10 Dec 2018 – 13 Dec 2018Foods & CosmeticsClean
23 Oct 2017 – 27 Oct 2017Human Drugs483View 483 →
9 Feb 2015 – 27 Feb 2015Human Drugs483View 483 →
9 Dec 2014 – 15 Dec 2014Human DrugsClean
18 Dec 2013Human DrugsClean
30 Nov 2012Not recorded483View 483 →
2 Nov 2012Not recorded483On file
25 Oct 2011Not recorded483View 483 →
25 May 2010Not recorded483View 483 →
6 Jun 2008Not recorded483On file

Observations on record

Form 483 observations cited at this site, most recent first.

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

27 Oct 2017
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Haroon Vohra

27 Feb 2015
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Edith M Gonzalez, Alan P Kurtzberg, Bryce A Hammer

Investigators

FDA investigators tied to this site in the record.

Alan P Kurtzberg2 insp.
Edith M Gonzalez2 insp.
Zachery L Miller2 insp.
Caroline H Le2 insp.
Oluwaseyi Ojinni1 insp.
Genoula K Ryan1 insp.
David A Gonzalez1 insp.
Haroon Vohra1 insp.
Bryce A Hammer1 insp.
Christine L Williams1 insp.
Robert J Burger1 insp.
Larisa E Pavlick1 insp.
Kimberley A Hoefen1 insp.
Michael E Maselli1 insp.
Michael R Goga1 insp.
Patricia D Stahnke1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 111.75(c)(3)Cited across public-safe Form 483 observations3x
21 CFR 111.105(i)Cited across public-safe Form 483 observations2x
21 CFR 111.117(b)Cited across public-safe Form 483 observations2x
21 CFR 111.65Cited across public-safe Form 483 observations2x
21 CFR 111.70(b)(3)Cited across public-safe Form 483 observations2x
21 CFR 111.70(c)(1)Cited across public-safe Form 483 observations2x
21 CFR 211.166(a)Cited across public-safe Form 483 observations2x
21 CFR 111.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 111.210(g)Cited across public-safe Form 483 observations1x
21 CFR 111.260(l)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.27(d)Cited across public-safe Form 483 observations1x
21 CFR 111.315(b)Cited across public-safe Form 483 observations1x
21 CFR 111.320(b)Cited across public-safe Form 483 observations1x
21 CFR 111.365Cited across public-safe Form 483 observations1x
21 CFR 111.365(i)Cited across public-safe Form 483 observations1x
21 CFR 111.55Cited 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
21 CFR 111.77(a)Cited across public-safe Form 483 observations1x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.103Cited across public-safe Form 483 observations1x
21 CFR 211.111Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind New Generation Wellness Inc.'s 8 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat