FDA Inspection 846710 — Cersys, Inc
The FDA completed an inspection of Cersys, Inc on Aug 23, 2013 in Miramar, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 23, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Miramar, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |