FDA Inspection
Response Biomedical Corp.Response Biomedical Corp. – FDA Inspection, Sep 13, 2018
Record Details
This FDA Inspection record concerns Response Biomedical Corp., with an inspection on September 13, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 42db7380-d946-4512-a756-dd2ed30c0092
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065491
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.72(b)Remedial action
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Other FDA inspections of Response Biomedical Corp.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 6, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Response Biomedical Corp.
- FDA Inspection 811028 - 2012-12-06
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