FDA Inspection
Osteotech, Inc.Osteotech, Inc. – FDA Inspection, Aug 10, 2017
Record Details
This FDA Inspection record concerns Osteotech, Inc., with an inspection on August 10, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e4a403d7-328b-4e7c-a1de-3e59c35cb327
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1021037
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
- 21 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
- 21 CFR 1271.195(c)Monitoring-microorganisms where appropriate
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Other FDA inspections of Osteotech, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| June 18, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 12, 2021 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 30, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 6, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 16, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Osteotech, Inc.
- FDA Inspection 1245789 - 2024-06-18
- FDA Inspection 1150237 - 2021-08-12
- FDA Inspection 1060874 - 2018-07-30
- FDA Inspection 925160 - 2015-05-06
- FDA Inspection 845708 - 2013-08-16
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