FDA Inspection 1294900 — American Pharma Mfg. Inc.
The FDA completed an inspection of American Pharma Mfg. Inc. on March 27, 2026 in Ontario, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 27, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Ontario, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15433 | 21 CFR 111.15(d)(1) | Animals and pests in facility |
| 15447 | 21 CFR 111.15(c)(3) | Cleaning compounds and toxic materials - holding |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15534 | 21 CFR 111.255(c) | Batch record - each step |
| 15720 | 21 CFR 111.370 | Rejected dietary supplements - identify, hold, control |
| 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 |
| 22824 | 21 CFR 111.15(f) | Plumbing |
| 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 |