FDA Inspection 738479 — Eastwestmed, Inc.
The FDA completed an inspection of Eastwestmed, Inc. on Aug 10, 2011 in Tiburon, 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 10, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tiburon, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |