FDA Inspection 818450 — James G Cole Inc dba ASN/Maxam Neutraceutics
The FDA completed an inspection of James G Cole Inc dba ASN/Maxam Neutraceutics on February 11, 2013 in Hood River, OR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 17 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 11, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Hood River, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15527 | 21 CFR 111.30(c) | Equipment - automated - QC check |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15544 | 21 CFR 111.260(d) | Batch record - component; unique identifier |
| 15545 | 21 CFR 111.260(e) | Batch record - component; identity, weight |
| 15600 | 21 CFR 111.160(d)(2) | Packaging, labels - unique identifier, disposition |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15743 | 21 CFR 111.210(h)(3) | Master manufacturing record - specific actions; quality |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15751 | 21 CFR 111.210(d) | Master manufacturing record - Supplemental Facts |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15898 | 21 CFR 111.83(b)(1) | Reserve sample -container-closure system |
| 16004 | 21 CFR 111.130(b) | Quality control operations -returned dietary supplement; salvage, redistribution |
| 16051 | 21 CFR 111.525(b) | Returned dietary supplement - release |