FDA Inspection
BioMimetic Therapeutics, LLCBioMimetic Therapeutics, LLC – FDA Inspection, Oct 23, 2017
Record Details
This FDA Inspection record concerns BioMimetic Therapeutics, LLC, with an inspection on October 23, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Bonnie E. Conley (Issuing Officer)
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ID · 304d45af-dd0b-40a1-bc54-7e3823542a22
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029464
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(g)Design validation- 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 BioMimetic Therapeutics, LLC
10| Date | Classification | Office | Project area |
|---|---|---|---|
| August 13, 2025 | Not classified | New Orleans District Office | |
| June 6, 2019 | Not classified | New Orleans District Office | |
| February 16, 2018 | Not classified | New Orleans District Office | |
| April 13, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| January 20, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for BioMimetic Therapeutics, LLC
- FDA Inspection 1281426 - 2025-08-13
- FDA Inspection 1099223 - 2019-06-06
- FDA Inspection 1081686 - 2018-02-16
- FDA Inspection 1007412 - 2017-04-13
- FDA Inspection 1001752 - 2017-01-20
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