FDA Inspection 814165 — Deep Freeze, LLC
The FDA completed an inspection of Deep Freeze, LLC on December 28, 2012 in Austin, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 28, 2012
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 4343 | 21 CFR 211.160(b)(1) | Incoming lots - conformance to written specs- |
| 4350 | 21 CFR 211.160(b)(3) | Drug products-sampling procedures/specifications |