FDA Inspection 622665 — Frantz Medical Development Ltd
The FDA completed an inspection of Frantz Medical Development Ltd on October 28, 2009 in Mentor, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 28, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mentor, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3250 | 21 CFR 820.72(b)(2) | Calibration documentation |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |