FDA Inspection 1099142 — South Bend Medical Foundation, Inc.
The FDA completed an inspection of South Bend Medical Foundation, Inc. on Aug 9, 2019 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
- Aug 9, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- South Bend, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |