FDA Inspection
Custom Healthcare Systems of VA, LLCCustom Healthcare Systems of VA, LLC – FDA Inspection, Sep 21, 2016
Record Details
This FDA Inspection record concerns Custom Healthcare Systems of VA, LLC, with an inspection on September 21, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 21, 2016
- Product Type
- Devices
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ID · b860fbfa-d79c-4577-8072-c84452e8e1da
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 987013
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.70(i)Software validation for automated processes
Showing 10 of 12 citations.
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Other FDA inspections of Custom Healthcare Systems of VA, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 26, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 26, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 4, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 5, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Custom Healthcare Systems of VA, LLC
- FDA Inspection 1243053 - 2024-06-26
- FDA Inspection 1191438 - 2022-10-26
- FDA Inspection 1101060 - 2019-09-04
- FDA Inspection 805859 - 2012-11-05
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