FDA Inspection 827299 — Total Nutrition Partners, LLC dba Total Nutrition Technology
The FDA completed an inspection of Total Nutrition Partners, LLC dba Total Nutrition Technology on April 4, 2013 in Leesburg, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 4, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Leesburg, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15842 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 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 |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15898 | 21 CFR 111.83(b)(1) | Reserve sample -container-closure system |
| 15950 | 21 CFR 111.110(b) | Quality control operations - tests, examinations |
| 15955 | 21 CFR 111.113(a)(3) | Quality control - adulteration; material review, disposition |
| 16047 | 21 CFR 111.510 | Returned dietary supplement - material review, disposition |