FDA Inspection 612341 — Barton-Carey Medical Products Inc
The FDA completed an inspection of Barton-Carey Medical Products Inc on Sep 4, 2009 in Maumee, OH. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 4, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Maumee, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3398 | 21 CFR 820.80(d)(3) | No release signature |
| 3399 | 21 CFR 820.80(d)(4) | No release authorization date |
| 4189 | 21 CFR 820.198(a) | General |