FDA Inspection 613005 — South Bend Medical Foundation, Inc.
The FDA completed an inspection of South Bend Medical Foundation, Inc. on Sep 11, 2009 in South Bend, IN. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 11, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- South Bend, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |