Overview
- 12 public-safe observations are available for this inspection.
- 12 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.
25 May 2010
21 CFR 111.65
Quality control - quality, dietary supplement
Cited by Kimberley A Hoefen, Caroline H Le
25 May 2010
21 CFR 111.75(c)(3)
Specifications met identity,purity, strength, comp; basis
Cited by Kimberley A Hoefen, Caroline H Le
25 May 2010
21 CFR 111.105(i)
QC - required operations master manufacturing/batch records
Cited by Kimberley A Hoefen, Caroline H Le
25 May 2010
21 CFR 111.117(b)
Quality control operations - calibration records
Cited by Kimberley A Hoefen, Caroline H Le
Inspected site
NGNew Generation Wellness Inc.Colorado Springs, United States
Inspection team
CHCaroline H Le
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.105(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.117(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(l)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
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 12 observations
The source PDF and every observation in full, 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