FDA Inspection 1085521 — Main Line Fertility Clinic P.C.
The FDA completed an inspection of Main Line Fertility Clinic P.C. on April 8, 2019 in Fort Washington, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 8, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fort Washington, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12238 | 21 CFR 1271.55(b)(1) | Statement re: certified testing lab |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |