FDA Inspection 832314 — South Bend Medical Foundation, Inc.
The FDA completed an inspection of South Bend Medical Foundation, Inc. on May 10, 2013 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). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 10, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- South Bend, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 98 | 21 CFR 606.100(c) | Thorough investigations |