FDA Inspection 1022464 — Bioactive Nutritional, Inc.
The FDA completed an inspection of Bioactive Nutritional, Inc. on August 22, 2017 in Melbourne, FL. 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
- August 22, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Melbourne, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15538 | 21 CFR 111.255(d) | Batch record - readily available |
| 15573 | 21 CFR 111.153 | Written procedures - product received; packaging, labeling |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15755 | 21 CFR 111.205(c) | Master manufacturing record: readily available |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |