Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
1 May 2026
21 CFR 111.113(a)(3)
Quality control - label; material review, disposition
Cited by Hanna S Louvau, Marion Valenzuela
1 May 2026
21 CFR 111.123(a)(1)
Quality control operations - master manufacturing record, modifications
Cited by Hanna S Louvau, Marion Valenzuela
1 May 2026
21 CFR 111.210
Master manufacturing record - record requirements
Cited by Hanna S Louvau, Marion Valenzuela
1 May 2026
21 CFR 111.260
Batch record - required information
Cited by Hanna S Louvau, Marion Valenzuela
1 May 2026
21 CFR 111.70(d)
Specifications - labels, packaging
Cited by Hanna S Louvau, Marion Valenzuela
Inspected site
KBKW Botanicals, Inc.San Anselmo, United States
Inspection team
MVMarion Valenzuela
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.113(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(d) | 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(a)(2) | 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 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