FDA Inspection
Tetra Medical Supply Corp.Tetra Medical Supply Corp. – FDA Inspection, Sep 28, 2017
Record Details
This FDA Inspection record concerns Tetra Medical Supply Corp., with an inspection on September 28, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 450b0d8c-7cc9-468f-aae8-cc238a4de048
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1027329
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Tetra Medical Supply Corp.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2016 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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