FDA Inspection 913173 — Repromed Fertility Center
The FDA completed an inspection of Repromed Fertility Center on February 6, 2015 in Dallas, TX. 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
- February 6, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |