FDA Inspection 678312 — Michigan Center for Fertility and Women's Health, PLC
The FDA completed an inspection of Michigan Center for Fertility and Women's Health, PLC on August 27, 2010 in Warren, 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
- August 27, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Warren, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |