FDA Inspection
Osteogenics Biomedical, Inc.Osteogenics Biomedical, Inc. – FDA Inspection, Jun 12, 2009
Record Details
This FDA Inspection record concerns Osteogenics Biomedical, Inc., with an inspection on June 12, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Osteogenics Biomedical, Inc.
- Inspection Date
- June 12, 2009
- Product Type
- Devices
View Company Profile
ID · f428bedc-adb3-48f3-b9c9-8f059ec21771
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 593365
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Osteogenics Biomedical, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 31, 2026 | Not classified | Dallas District Office | |
| May 23, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 10, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 2, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Osteogenics Biomedical, Inc.
- FDA Inspection 1331348 - 2026-07-31
- FDA Inspection 1057041 - 2018-05-23
- FDA Inspection 858888 - 2013-12-10
- FDA Inspection 755668 - 2011-12-02
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