FDA Inspection 911633 — TerraVare, Inc.
The FDA completed an inspection of TerraVare, Inc. on February 3, 2015 in Skaneateles, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 3, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Skaneateles, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15549 | 21 CFR 111.260(i) | Batch record - specifications |
| 15554 | 21 CFR 111.260(j)(2)(ii) | Batch record - initials; verifying weight |
| 15560 | 21 CFR 111.260(k)(2) | Batch record - label |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15785 | 21 CFR 111.410(b) | Label, packaging - discrepancies |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |
| 3659 | 21 CFR 110.37(e)(3) | Hand drying |