FDA Inspection 1259645 — STPCA Inc.
The FDA completed an inspection of STPCA Inc. on January 24, 2025 in Irvine, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 24, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22844 | 21 CFR 111.70(c)(1) | In-process specification |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22863 | 21 CFR 111.110 | Quality control - Laboratory control processes; production, process control |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |