FDA Inspection 1148373 — Women & Infants Hospital Of Rhode Island Women & Infants' Fertility Center
The FDA completed an inspection of Women & Infants Hospital Of Rhode Island Women & Infants' Fertility Center on August 10, 2021 in Providence, RI. 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
- August 10, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Providence, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |