FDA Inspection 967571 — Mountain Meadow Herbs, Inc.
The FDA completed an inspection of Mountain Meadow Herbs, Inc. on March 16, 2016 in Somers, MT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 16, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Somers, MT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15547 | 21 CFR 111.260(g) | Batch record - results; monitoring |
| 15548 | 21 CFR 111.260(h) | Batch record - results; testing, examination; batch |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15671 | 21 CFR 111.315 | Laboratory control processes - requirements |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15752 | 21 CFR 111.210(c) | Master manufacturing record - components; weight, measure |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15964 | 21 CFR 111.113(c) | Document - material review, disposition |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |