FDA Inspection 990464 — ORM Fertility LLC
The FDA completed an inspection of ORM Fertility LLC on Nov 4, 2016 in Bellevue, 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 4, 2016
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Bellevue, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12250 | 21 CFR 1271.55(d)(4) | Ten year retention |
| 12283 | 21 CFR 1271.75(e) | Abbreviated procedure |
| 12290 | 21 CFR 1271.80(d)(1) | Reactive tests--not determined ineligible |