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.
11 Apr 2025
21 CFR 111.103
Written procedures - establish; quality control operations
Cited by Dariusz Galezowski, Jennifer R Johnson, Brian J Davis
11 Apr 2025
21 CFR 111.113(b)(2)
Quality control - reject; specification not met
Cited by Dariusz Galezowski, Jennifer R Johnson, Brian J Davis
11 Apr 2025
21 CFR 111.210
Master manufacturing record - record requirements
Cited by Dariusz Galezowski, Jennifer R Johnson, Brian J Davis
11 Apr 2025
21 CFR 111.475(b)
Records - written procedures holding and distribution; product distribution
Cited by Dariusz Galezowski, Jennifer R Johnson, Brian J Davis
11 Apr 2025
21 CFR 111.70(b)
Specifications - components
Cited by Dariusz Galezowski, Jennifer R Johnson, Brian J Davis
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 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.475(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | 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