FDA Inspection 746444 — South Bend Medical Foundation, Inc.
The FDA completed an inspection of South Bend Medical Foundation, Inc. on September 22, 2011 in South Bend, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 22, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- South Bend, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |