FDA Inspection 579781 — Organ Procurement Agency of Michigan
The FDA completed an inspection of Organ Procurement Agency of Michigan on April 23, 2009 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 23, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Ann Arbor, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12225 | 21 CFR 1271.47(d) | Departures: recording and justifying |
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |