FDA Inspection 782534 — Rapid Diagnostics, Division Of Mp Biomedicals, Llc
The FDA completed an inspection of Rapid Diagnostics, Division Of Mp Biomedicals, Llc on May 14, 2012 in Burlingame, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 14, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Burlingame, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |