FDA Inspection 974123 — Eden's Answers Inc
The FDA completed an inspection of Eden's Answers Inc on June 8, 2016 in Holmesville, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 11 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 8, 2016
- Fiscal Year
- 2016
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Holmesville, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15391 | 21 CFR 111.10(b)(3) | Hand washing |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15549 | 21 CFR 111.260(i) | Batch record - specifications |
| 15740 | 21 CFR 111.210(h)(3)(ii)(A) | Instructions; components; weight, measure |
| 15754 | 21 CFR 111.210(a) | Master manufacturing record - dietary ingredients |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16007 | 21 CFR 111.135 | Quality control operations - product complaints |