FDA Inspection
Custom Healthcare Systems of VA, LLCCustom Healthcare Systems of VA, LLC – FDA Inspection, Sep 4, 2019
Record Details
This FDA Inspection record concerns Custom Healthcare Systems of VA, LLC, with an inspection on September 4, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ab5a7106-78aa-41cb-b584-5fdebce04949
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101060
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
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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 21, 2016 | 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 987013 - 2016-09-21
- FDA Inspection 805859 - 2012-11-05
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