FDA Inspection 774152 — Bio-Derm Laboratories, Inc
The FDA completed an inspection of Bio-Derm Laboratories, Inc on March 30, 2012 in Longview, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 30, 2012
- Fiscal Year
- 2012
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Longview, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |