FDA Inspection 995541 — Grifols Bio Supplies Inc
The FDA completed an inspection of Grifols Bio Supplies Inc on Dec 13, 2016 in Philadelphia, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 13, 2016
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18041 | 21 CFR 606.160(e)(2) | Cumulative deferral record HTLV, Chagas |
| 18044 | 21 CFR 610.40(a)(2) | Test for HTLV, syphilis, West Nile, Chagas |
| 18082 | 21 CFR 630.10(e)(2) | Additional Medical Assessment Factors |
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 18096 | 21 CFR 630.10(g)(2)(ii) | Donor's Acknowledgment - Exculpatory language |