FDA Inspection 684642 — Organ Procurement Agency of Michigan
The FDA completed an inspection of Organ Procurement Agency of Michigan on October 5, 2010 in Ann Arbor, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 5, 2010
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Ann Arbor, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12422 | 21 CFR 1271.265(b) | Shipment of HCT/Ps - pre-established criteria |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |
| 12438 | 21 CFR 1271.270(b) | Management system re: core CGTPs |
| 15019 | 21 CFR 1271.160(d) | Computer software verification |