FDA Inspection 961856 — TerraVare, Inc.
The FDA completed an inspection of TerraVare, Inc. on March 8, 2016 in Skaneateles, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 8, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Skaneateles, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15549 | 21 CFR 111.260(i) | Batch record - specifications |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |