FDA Inspection 905629 — Scientific Medical Systems/Idant Laboratories
The FDA completed an inspection of Scientific Medical Systems/Idant Laboratories on December 12, 2014 in New York, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 12, 2014
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12278 | 21 CFR 1271.75(a)(2) | Risks associated with xenotransplantation |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12495 | 21 CFR 1271.85(d) | Retesting of semen donors |
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |