Overview
- 8 public-safe observations are available for this inspection.
- 4 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.
28 Aug 2018
21 CFR 111.165(e)
Product received - mix-ups
Cited by Jennifer A D'Angelo, Latoya A Griffith
28 Aug 2018
21 CFR 111.165(e)
Product received - mix-ups
Cited by Jennifer A D'Angelo, Latoya A Griffith
28 Aug 2018
21 CFR 111.210(h)(5)
Corrective action plans
Cited by Jennifer A D'Angelo, Latoya A Griffith
28 Aug 2018
21 CFR 111.210(h)(5)
Corrective action plans
Cited by Jennifer A D'Angelo, Latoya A Griffith
28 Aug 2018
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Jennifer A D'Angelo, Latoya A Griffith
Inspected site
SNSalud Natural Entrepreneur, Inc.Waukegan, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(h)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 8 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