FDA Inspection 881712 — Musculoskeletal Transplant Foundation, Inc.
The FDA completed an inspection of Musculoskeletal Transplant Foundation, Inc. on May 19, 2014 in Edison, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 13 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 19, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Edison, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12319 | 21 CFR 1271.160(b)(3) | Actions taken and documented |
| 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 |
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12387 | 21 CFR 1271.220(a) | Causing contamination, increasing risks |
| 12406 | 21 CFR 1271.250(a) | Design of labeling procedures |
| 12459 | 21 CFR 1271.320(b) | Sufficient information to draw conclusions |
| 12460 | 21 CFR 1271.320(c) | Review and evaluation, report to FDA |
| 12468 | 21 CFR 1271.350(a)(1) | Investigation of adverse reactions |
| 12469 | 21 CFR 1271.350(a)(1) | Adverse reaction reporting to FDA |
| 12470 | 21 CFR 1271.350(a)(2) | 15 day reporting timeframe |
| 12473 | 21 CFR 1271.350(b)(2) | Deviations not reported to FDA |