FDA Inspection 920278 — Terra Firma Botanicals Inc
The FDA completed an inspection of Terra Firma Botanicals Inc on March 19, 2015 in Eugene, OR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 19, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Eugene, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15598 | 21 CFR 111.160(d)(1) | Packaging - identify |
| 15599 | 21 CFR 111.160(d)(1) | Labels - identify |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |