FDA Inspection 806750 — Benjamin Biomedical, Inc.
The FDA completed an inspection of Benjamin Biomedical, Inc. on November 2, 2012 in St Petersburg, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 2, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- St Petersburg, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |