FDA Inspection 1154990 — Evercrete International, Inc.
The FDA completed an inspection of Evercrete International, Inc. on October 20, 2021 in Saint George, UT. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 20, 2021
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Saint George, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15511 | 21 CFR 111.27(d) | Equipment - maintain - general |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 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 |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 16037 | 21 CFR 111.605 | Records - keep: 1 year, 2 years |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |