Overview
- 8 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
10 Apr 2015
21 CFR 111.560(a)(1)
Product complaint - quality control review
Cited by Edward M James, Lauren E Sanger, Lauren E Merz
10 Apr 2015
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Edward M James, Lauren E Sanger, Lauren E Merz
10 Apr 2015
21 CFR 111.77(a)
Specifications not met - reject, quality control
Cited by Edward M James, Lauren E Sanger, Lauren E Merz
10 Apr 2015
FDCA 761(b)(1)
No AE report made (dietary supplement)
Cited by Edward M James, Lauren E Sanger, Lauren E Merz
10 Apr 2015
21 CFR 111.560(a)(1)
Product complaint - quality control review
Cited by Edward M James, Lauren E Sanger, Lauren E Merz
Inspected site
NMNutri-Dyn Midwest, Inc.Maple Plain, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.560(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.77(a) | Cited across public-safe Form 483 observations | 2x |
| FDCA 761(b)(1) | Cited across public-safe Form 483 observations | 2x |
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 8 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