FDA Inspection
VCI ACQUISITION, LLCVCI ACQUISITION, LLC – FDA Inspection, Mar 13, 2018
Record Details
This FDA Inspection record concerns VCI ACQUISITION, LLC, with an inspection on March 13, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 86d5e06d-9f80-4c1b-a445-eb379222405a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1045098
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of VCI ACQUISITION, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 10, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for VCI ACQUISITION, LLC
- FDA Inspection 846143 - 2013-08-28
- FDA Inspection 629952 - 2009-11-10
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