FDA Inspection 1272645 — Kettering Medical Center
The FDA completed an inspection of Kettering Medical Center on May 9, 2025 in Kettering, OH. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 9, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kettering, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17755 | 21 CFR 212.20(a) | Oversight of production operations |
| 17816 | 21 CFR 212.50(c) | Unique record for each batch |
| 17941 | 21 CFR 212.71(b) | Documentation of Non-Conforming Product Investigation |