FDA Inspection
HTA Direct SourcingHTA Direct Sourcing – FDA Inspection, Jul 18, 2012
Record Details
This FDA Inspection record concerns HTA Direct Sourcing, with an inspection on July 18, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- HTA Direct Sourcing
- Inspection Date
- July 18, 2012
- Product Type
- Devices
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ID · 98247af2-6bcf-4ff8-8eb3-1be3946056ce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 790833
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of HTA Direct Sourcing
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 24, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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