FDA Inspection 799774 — Earthborn Products Inc
The FDA completed an inspection of Earthborn Products Inc on September 25, 2012 in San Diego, CA. 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
- September 25, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15381 | 21 CFR 111.8 | Written procedures - hygienic practices |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15525 | 21 CFR 111.30(b) | Equipment - automated - suitability |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15745 | 21 CFR 111.210(h)(1) | Instructions; specifications; packaged, labeled |
| 15746 | 21 CFR 111.210(h)(1) | Instructions; specifications; quality |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |