FDA Inspection
Healthcare-id, Inc.Healthcare-id, Inc. – FDA Inspection, Sep 1, 2017
Record Details
This FDA Inspection record concerns Healthcare-id, Inc., with an inspection on September 1, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8b387718-5de0-4b9e-862c-b50d5a0c17ad
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1023754
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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Other FDA inspections of Healthcare-id, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 18, 2024 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 14, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 12, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Healthcare-id, Inc.
- FDA Inspection 1244631 - 2024-07-18
- FDA Inspection 878768 - 2014-05-14
- FDA Inspection 645961 - 2010-02-12
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