FDA Inspection 668326 — Spectrum Brands Pet Group Inc
The FDA completed an inspection of Spectrum Brands Pet Group Inc on July 1, 2010 in Blacksburg, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 1, 2010
- Fiscal Year
- 2010
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Blacksburg, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1554 | 21 CFR 110.35(a) | Cleaning and sanitizing operations |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |