FDA Inspection
HealthCare Products, Inc.HealthCare Products, Inc. – FDA Inspection, Aug 30, 2019
Record Details
This FDA Inspection record concerns HealthCare Products, Inc., with an inspection on August 30, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ae46e9f9-dbbe-4797-a646-32c60f02f393
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1100933
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of HealthCare Products, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 8, 2026 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 10, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 24, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 16, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for HealthCare Products, Inc.
- FDA Inspection 1325574 - 2026-07-08
- FDA Inspection 726990 - 2011-05-10
- FDA Inspection 669025 - 2010-06-24
- FDA Inspection 612657 - 2009-09-16
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