FDA Inspection 719483 — Deep Freeze, LLC
The FDA completed an inspection of Deep Freeze, LLC on April 28, 2011 in Austin, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 28, 2011
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 4347 | 21 CFR 211.160(b)(2) | In process materials - conformance to written specs |
| 4350 | 21 CFR 211.160(b)(3) | Drug products-sampling procedures/specifications |