FDA Inspection 1256489 — Curtis Jacquot dba Pacific BioLogic Co.
The FDA completed an inspection of Curtis Jacquot dba Pacific BioLogic Co. on December 13, 2024 in Concord, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 13, 2024
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Concord, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15726 | 21 CFR 111.365(f) | Holding - prevent becoming adulterated |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22911 | 21 CFR 111.535(b) | Make and keep records - returned dietary supplements |
| 22915 | 21 CFR 111.570(b) | Records - written procedures; product complaint |