FDA Inspection 1036342 — West Coast Fertility Centers, LLC
The FDA completed an inspection of West Coast Fertility Centers, LLC on December 27, 2017 in Fountain Valley, CA. 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
- December 27, 2017
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- 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 |