FDA Inspection 657363 — MP Biomedicals Diagnostics Division
The FDA completed an inspection of MP Biomedicals Diagnostics Division on April 22, 2010 in Solon, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 22, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Solon, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |