FDA Inspection 635373 — ALPHIA Incorporated
The FDA completed an inspection of ALPHIA Incorporated on Dec 17, 2009 in Ogden, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 17, 2009
- Fiscal Year
- 2010
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Ogden, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1560 | 21 CFR 110.35(c) | Lack of effective pest exclusion |
| 1642 | 21 CFR 113.100(b) | Review not signed/dated |
| 2321 | 21 CFR 113.40(c)(2)(iii) | Unauthorized adjustment |
| 2864 | 21 CFR 113.40(g)(1)(ii)(B) | Temp drop - deviation or other variation (S) |
| 3655 | 21 CFR 110.37(d)(2) | Good repair |
| 3877 | 21 CFR 113.60(c) | Coding - required elements |