FDA Inspection 614635 — Musculoskeletal Transplant Foundation
The FDA completed an inspection of Musculoskeletal Transplant Foundation on August 19, 2009 in Syracuse, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 19, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Syracuse, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12311 | 21 CFR 1271.160(b)(1) | Ensuring appropriate core requirements followed |
| 12322 | 21 CFR 1271.160(b)(4) | Training of personnel |
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 15020 | 21 CFR 1271.200(e) | Documentation of maintenance and cleaning |