FDA Inspection
Musculoskeletal Transplant Foundation, Inc.Musculoskeletal Transplant Foundation, Inc. – FDA Inspection, Nov 30, 2012
Record Details
This FDA Inspection record concerns Musculoskeletal Transplant Foundation, Inc., with an inspection on November 30, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 30, 2012
- Product Type
- Biologics
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ID · 70d8104e-40d3-43d0-95ec-669d1b542015
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 810372
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
15- 21 CFR 1271.320(c)Reportable events not investigated
- 21 CFR 1271.320(c)Review and evaluation, report to FDA
- 21 CFR 1271.195(c)Monitoring-microorganisms where appropriate
- 21 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
- 21 CFR 1271.265(c)(2)Improperly released for distribution
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.225Verification/validation
- 21 CFR 1271.230(a)Validation & approval--established procedures
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Other FDA inspections of Musculoskeletal Transplant Foundation, Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| August 4, 2026 | Not classified | New Jersey District Office | Human Cellular, Tissue, and Gene Therapies |
| June 21, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 9, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 17, 2021 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 18, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Musculoskeletal Transplant Foundation, Inc.
- FDA Inspection 1329314 - 2026-08-04
- FDA Inspection 1229385 - 2024-06-21
- FDA Inspection 1166490 - 2022-03-09
- FDA Inspection 1160012 - 2021-11-17
- FDA Inspection 1038552 - 2018-01-18
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