FDA Inspection 774360 — Freudenberg Medical, LLC
The FDA completed an inspection of Freudenberg Medical, LLC on Mar 27, 2012 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 27, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Carpinteria, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |