FDA Inspection 1195562 — Island Reproductive Services
The FDA completed an inspection of Island Reproductive Services on Jan 26, 2023 in Staten Island, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Jan 26, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Staten Island, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |