FDA Inspection 1099160 — Chaga Mountain, Inc.
The FDA completed an inspection of Chaga Mountain, Inc. on August 7, 2019 in Jackman, ME. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 7, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Jackman, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15584 | 21 CFR 111.155(d)(1) | Components - identify lot produced |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |