FDA Inspection 1071848 — A6 Supplements, Inc. dba Red Rock Supplements, Inc. & Health Tech International, Inc.
The FDA completed an inspection of A6 Supplements, Inc. dba Red Rock Supplements, Inc. & Health Tech International, Inc. on November 16, 2018 in Saint George, UT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 16, 2018
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Saint George, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15481 | 21 CFR 111.23(b) | Records - cleaning, pest control |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15751 | 21 CFR 111.210(d) | Master manufacturing record - Supplemental Facts |
| 15783 | 21 CFR 111.410(d) | Manufacturing history |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15938 | 21 CFR 111.105(f) | Quality control - representative samples |
| 15977 | 21 CFR 111.123(a)(1) | Quality control operations - master manufacturing record, modifications |
| 15978 | 21 CFR 111.123(a)(2) | Quality control operations - batch production records |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |