FDA Inspection 797568 — Barton-Carey Medical Products Inc
The FDA completed an inspection of Barton-Carey Medical Products Inc on August 10, 2012 in Maumee, OH. 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
- August 10, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Maumee, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |