FDA Inspection 1200793 — Bethesda Fertility Center
The FDA completed an inspection of Bethesda Fertility Center on March 22, 2023 in Montgomery, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 22, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Montgomery, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12241 | 21 CFR 1271.55(b)(4) | Reasons for ineligibility on summary |
| 12270 | 21 CFR 1271.65(a) | Improper release prevention--storage, I.D. |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12283 | 21 CFR 1271.75(e) | Abbreviated procedure |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |