FDA Inspection 1278895 — NCFMC, A Medical Corporation
The FDA completed an inspection of NCFMC, A Medical Corporation on Aug 19, 2025 in Sacramento, CA. 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 19, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Sacramento, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12288 | 21 CFR 1271.80(c) | Manufacturer instructions not followed |