FDA Inspection 557498 — Constant Irwindale, Inc.
The FDA completed an inspection of Constant Irwindale, Inc. on January 16, 2009 in Irwindale, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 16, 2009
- Fiscal Year
- 2009
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Irwindale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |