FDA Inspection
Tetra Medical Supply Corp.Tetra Medical Supply Corp. – FDA Inspection, Apr 22, 2016
Record Details
This FDA Inspection record concerns Tetra Medical Supply Corp., with an inspection on April 22, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tetra Medical Supply Corp.
- Inspection Date
- April 22, 2016
- Product Type
- Devices
View Company Profile
ID · 8cb3cf91-1590-4dfa-bdda-46850af4524a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 975437
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Tetra Medical Supply Corp.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 28, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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