FDA Inspection 1225062 — Community Healthcare System
The FDA completed an inspection of Community Healthcare System on Dec 15, 2023 in Munster, 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 15, 2023
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Munster, IN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7334 | 21 CFR 56.115(a)(5) | List of members |