FDA Inspection 1149281 — Bodyhealth.com, LLC
The FDA completed an inspection of Bodyhealth.com, LLC on August 20, 2021 in Dunedin, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 20, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Dunedin, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15989 | 21 CFR 111.127 | Quality control operations - packaging, labeling |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |