FDA Inspection 988670 — Evercrete International, Inc.
The FDA completed an inspection of Evercrete International, Inc. on August 8, 2016 in Saint George, UT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 8, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Saint George, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15409 | 21 CFR 111.14(b)(1) | Personnel - records - written procedures |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |