FDA Inspection 1036342 — West Coast Fertility Centers, LLC
The FDA completed an inspection of West Coast Fertility Centers, LLC on Dec 27, 2017 in Fountain Valley, CA. 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
- Dec 27, 2017
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fountain Valley, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |