FDA Inspection 674577 — Musculoskeletal Transplant Foundation, Inc.
The FDA completed an inspection of Musculoskeletal Transplant Foundation, Inc. on July 30, 2010 in Edison, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 30, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Edison, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12231 | 21 CFR 1271.50(b)(1) | Donor screening standards |
| 12343 | 21 CFR 1271.190(a) | State of repair |
| 12351 | 21 CFR 1271.190(d)(1) | Procedures for cleaning, sanitation |
| 12375 | 21 CFR 1271.210(a) | Use prior to verification |
| 12387 | 21 CFR 1271.220(a) | Causing contamination, increasing risks |
| 12405 | 21 CFR 1271.250(a) | Controlling the labeling of HCT/Ps |
| 12411 | 21 CFR 1271.260(a) | Contamination, mix ups, improper release |
| 12414 | 21 CFR 1271.260(d) | Corrective actions |
| 15020 | 21 CFR 1271.200(e) | Documentation of maintenance and cleaning |