FDA Inspection 1054339 — Reproductive Endocrine Center Sperm Physiology Lab
The FDA completed an inspection of Reproductive Endocrine Center Sperm Physiology Lab on May 31, 2018 in Orange, CT. 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
- May 31, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Orange, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |