FDA Inspection 917514 — Eidon Inc.
The FDA completed an inspection of Eidon Inc. on March 5, 2015 in Poway, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 22 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 5, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Poway, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15382 | 21 CFR 111.8 | Written procedures - personnel qualifications |
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15446 | 21 CFR 111.15(c)(2) | Toxic materials - use |
| 15480 | 21 CFR 111.20(h) | Physical plant - screening against pests |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15510 | 21 CFR 111.27(a)(7) | Compressed air, gases |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15572 | 21 CFR 111.153 | Written procedures - labels |
| 15598 | 21 CFR 111.160(d)(1) | Packaging - identify |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15739 | 21 CFR 111.210(h)(3)(ii)(B) | Components; add, verify |
| 15741 | 21 CFR 111.210(h)(3)(i) | Components, verify weight, measure |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15845 | 21 CFR 111.73 | Specifications met - quality |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |