FDA Inspection 801130 — Musculoskeletal Transplant Foundation, Inc.
The FDA completed an inspection of Musculoskeletal Transplant Foundation, Inc. on October 18, 2012 in Jessup, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 18, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Jessup, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12323 | 21 CFR 1271.160(b)(5) | Monitoring systems |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12363 | 21 CFR 1271.195(c) | Monitoring--cross contamination, exposure to CD |