FDA Inspection 902211 — Poma Fertility, LLC
The FDA completed an inspection of Poma Fertility, LLC on Nov 4, 2014 in Kirkland, WA. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 4, 2014
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Kirkland, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12283 | 21 CFR 1271.75(e) | Abbreviated procedure |