FDA Inspection 1036164 — VetStem
The FDA completed an inspection of VetStem on Dec 27, 2017 in Poway, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 27, 2017
- Fiscal Year
- 2018
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Poway, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4317 | 21 CFR 211.84(d)(3) | Certificates of Testing (Containers, Closures) |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |