FDA Inspection 841637 — Spectrum Brands Pet Group Inc
The FDA completed an inspection of Spectrum Brands Pet Group Inc on August 7, 2013 in Blacksburg, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 7, 2013
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Blacksburg, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 17869 | 21 CFR 212.61(a) | Samples representative, stored properly |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |