FDA Inspection 719414 — LifeSource Cryobank, LLC
The FDA completed an inspection of LifeSource Cryobank, LLC on Mar 31, 2011 in Covington, LA. 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). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 31, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Covington, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12365 | 21 CFR 1271.195(d) | Documentation not maintained |
| 12382 | 21 CFR 1271.210(d)(3) | Lot documentation maintained |
| 12405 | 21 CFR 1271.250(a) | Controlling the labeling of HCT/Ps |
| 12413 | 21 CFR 1271.260(c) | Expiration date factors |
| 12453 | 21 CFR 1271.290(e) | Documenting disposition of each HCT/P |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |
| 12489 | 21 CFR 1271.90(c)(1) | Autologous use only--labeling |
| 6515 | 21 CFR 1240.65 | Lack of permit |