FDA Inspection
Osteomed, LLCOsteomed, LLC – FDA Inspection, Sep 22, 2017
Record Details
This FDA Inspection record concerns Osteomed, LLC, with an inspection on September 22, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cce3738e-e82a-435b-9f7d-be72d6637cc2
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1026378
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of Osteomed, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 16, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 28, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 7, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 28, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Osteomed, LLC
- FDA Inspection 1278352 - 2025-08-08
- FDA Inspection 1232268 - 2024-08-16
- FDA Inspection 1217195 - 2023-08-28
- FDA Inspection 955878 - 2016-01-07
- FDA Inspection 868667 - 2014-02-28
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