FDA Inspection 1157007 — High Five Drink Inc.
The FDA completed an inspection of High Five Drink Inc. on Nov 18, 2021 in Farmers Branch, TX. 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). 16 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 18, 2021
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Farmers Branch, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15734 | 21 CFR 111.360 | Manufacturing operations - sanitation |
| 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 |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |
| 15938 | 21 CFR 111.105(f) | Quality control - representative samples |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |
| 19078 | 21 CFR 117.139(a) | Recall plan - Written |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |