FDA Inspection 774839 — Basic Organics Inc
The FDA completed an inspection of Basic Organics Inc on April 6, 2012 in Gahanna, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 6, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Gahanna, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15409 | 21 CFR 111.14(b)(1) | Personnel - records - written procedures |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15549 | 21 CFR 111.260(i) | Batch record - specifications |
| 15573 | 21 CFR 111.153 | Written procedures - product received; packaging, labeling |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |