FDA Inspection 814410 — Freudenberg Medical, LLC
The FDA completed an inspection of Freudenberg Medical, LLC on Jan 18, 2013 in Carpinteria, CA. 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 18, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Carpinteria, CA (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |