FDA Inspection 916288 — Rapid Diagnostics, Division Of Mp Biomedicals, Llc
The FDA completed an inspection of Rapid Diagnostics, Division Of Mp Biomedicals, Llc on March 2, 2015 in Burlingame, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 2, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Burlingame, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14711 | 21 CFR 820.160(a) | Lack of or inadequate procedures for distribution |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |