FDA Inspection 859009 — Xytex Cryo International
The FDA completed an inspection of Xytex Cryo International on Dec 16, 2013 in New Brunswick, NJ. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 16, 2013
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New Brunswick, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12254 | 21 CFR 1271.60(b) | Identified as quarantined, distinguishable |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |