FDA Inspection 810372 — Musculoskeletal Transplant Foundation, Inc.
The FDA completed an inspection of Musculoskeletal Transplant Foundation, Inc. on November 30, 2012 in Edison, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 30, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Edison, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12311 | 21 CFR 1271.160(b)(1) | Ensuring appropriate core requirements followed |
| 12322 | 21 CFR 1271.160(b)(4) | Training of personnel |
| 12323 | 21 CFR 1271.160(b)(5) | Monitoring systems |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12359 | 21 CFR 1271.195(a)(3) | Aseptic processing---cleaning, disinfecting |
| 12364 | 21 CFR 1271.195(c) | Monitoring-microorganisms where appropriate |
| 12395 | 21 CFR 1271.225 | Verification/validation |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12426 | 21 CFR 1271.265(c)(2) | Improperly released for distribution |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |
| 12439 | 21 CFR 1271.270(b) | Organized to facilitate review |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |
| 12460 | 21 CFR 1271.320(c) | Review and evaluation, report to FDA |
| 12461 | 21 CFR 1271.320(c) | Reportable events not investigated |