FDA Inspection
Highridge Medical LLCHighridge Medical LLC – FDA Inspection, Mar 1, 2018
Record Details
This FDA Inspection record concerns Highridge Medical LLC, with an inspection on March 1, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · deed496c-00b6-439a-8796-2c7fb96354b5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042767
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
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Other FDA inspections of Highridge Medical LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 6, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 24, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Highridge Medical LLC
- FDA Inspection 1043760 - 2018-01-17
- FDA Inspection 898988 - 2014-10-06
- FDA Inspection 714332 - 2011-02-24
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