FDA Inspection 737518 — Benz Research And Development Corporation
The FDA completed an inspection of Benz Research And Development Corporation on August 3, 2011 in Sarasota, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 3, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sarasota, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |