FDA Inspection 1036155 — Vitalyte Sports Nutrition Inc.
The FDA completed an inspection of Vitalyte Sports Nutrition Inc. on Dec 20, 2017 in Escondido, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 20, 2017
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Escondido, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15409 | 21 CFR 111.14(b)(1) | Personnel - records - written procedures |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15619 | 21 CFR 111.180(b)(1) | Written procedures - packaging, labeling received |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16045 | 21 CFR 111.503 | Written procedures returned dietary supplement; reprocessing |