FDA Inspection 923746 — Wassenburg Medical, Inc.
The FDA completed an inspection of Wassenburg Medical, Inc. on April 24, 2015 in Ivyland, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 24, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ivyland, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |