Overview
- 9 public-safe observations are available for this inspection.
- 9 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.
12 Mar 2025
21 CFR 111.105(a)
Quality control - processes, specifications, written procedures
Cited by Oluwaseyi Ojinni, Mikayla K Turner
12 Mar 2025
21 CFR 111.105(h)
Quality control - production, process control
Cited by Oluwaseyi Ojinni, Mikayla K Turner
12 Mar 2025
21 CFR 111.155(c)(3)
Quality control - components, approve, release
Cited by Oluwaseyi Ojinni, Mikayla K Turner
12 Mar 2025
21 CFR 111.210
Master manufacturing record - record requirements
Cited by Oluwaseyi Ojinni, Mikayla K Turner
Inspected site
WBWESTERN BOTANICALS FL, LLCSpanish Fork, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.10(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105(h) | 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 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(d) | 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 111.77(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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