FDA Inspection
Highridge Medical LLCHighridge Medical LLC – FDA Inspection, Oct 6, 2014
Record Details
This FDA Inspection record concerns Highridge Medical LLC, with an inspection on October 6, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Highridge Medical LLC
- Inspection Date
- October 6, 2014
- Product Type
- Biologics
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ID · cce0cae9-9147-468a-ae72-132eadd5040b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 898988
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 1271.250(a)Controlling the labeling of HCT/Ps
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Highridge Medical LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 1, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 17, 2018 | NAI | 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 1042767 - 2018-03-01
- FDA Inspection 1043760 - 2018-01-17
- FDA Inspection 714332 - 2011-02-24
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