Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
25 Sep 2023
21 CFR 111.113(b)(2)
Quality control - reject; specification not met
Cited by Jennifer A D'Angelo, Logan M Ebeling, Renee L Anderson
25 Sep 2023
21 CFR 111.155(c)(3)
Quality control - components, approve, release
Cited by Jennifer A D'Angelo, Logan M Ebeling, Renee L Anderson
25 Sep 2023
21 CFR 111.210(c)
Master manufacturing record - components; weight, measure
Cited by Jennifer A D'Angelo, Logan M Ebeling, Renee L Anderson
25 Sep 2023
21 CFR 111.255(c)
Batch record - follow master
Cited by Jennifer A D'Angelo, Logan M Ebeling, Renee L Anderson
25 Sep 2023
21 CFR 111.25(a)
Procedures - calibrating instruments
Cited by Jennifer A D'Angelo, Logan M Ebeling, Renee L Anderson
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 111.113(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.77(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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