FDA Inspection
Home Aide Diagnostics IncHome Aide Diagnostics Inc – FDA Inspection, Sep 30, 2019
Record Details
This FDA Inspection record concerns Home Aide Diagnostics Inc, with an inspection on September 30, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 543f038f-3e40-439b-a0bd-4fbada3a333b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1103537
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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Other FDA inspections of Home Aide Diagnostics Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 23, 2015 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for Home Aide Diagnostics Inc
- FDA Inspection 1004336 - 2015-12-23
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