FDA Inspection 1282806 — APEXCM, INC.
The FDA completed an inspection of APEXCM, INC. on September 18, 2025 in Tampa, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 18, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1 | 21 CFR 11 | Electronic records |
| 15673 | 21 CFR 111.315(a) | Criteria for establishing specifications |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22886 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications, quality; packaging, labeling |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22897 | 21 CFR 111.325(b) | Make and keep records - laboratory operations |