FDA Inspection 599704 — Reproductive Medicine Associates Of Michigan, PLC
The FDA completed an inspection of Reproductive Medicine Associates Of Michigan, PLC on Jul 27, 2009 in Troy, MI. 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 27, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Troy, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12232 | 21 CFR 1271.50(b)(2) | Donor testing not negative for CD agents |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12252 | 21 CFR 1271.60(a) | Completion of eligibility determination |
| 12290 | 21 CFR 1271.80(d)(1) | Reactive tests--not determined ineligible |