FDA Inspection 549490 — CryoGam Colorado, LLC.
The FDA completed an inspection of CryoGam Colorado, LLC. on Nov 19, 2008 in Loveland, CO. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 19, 2008
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Loveland, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12253 | 21 CFR 1271.60(a) | Semen retesting quarantine |
| 12254 | 21 CFR 1271.60(b) | Identified as quarantined, distinguishable |
| 12283 | 21 CFR 1271.75(e) | Abbreviated procedure |