FDA Inspection
HQ, Inc.HQ, Inc. – FDA Inspection, Sep 22, 2017
Record Details
This FDA Inspection record concerns HQ, Inc., with an inspection on September 22, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · efd0fb6c-6aea-408c-97f6-e879cd2ec6dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1026395
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.86Acceptance status
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of HQ, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 30, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 3, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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