FDA Inspection
J & M Urinary Catheters, LLCJ & M Urinary Catheters, LLC – FDA Inspection, Dec 6, 2018
Record Details
This FDA Inspection record concerns J & M Urinary Catheters, LLC, with an inspection on December 6, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 93573ee6-5e79-4a50-bca4-52620dc920ea
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1074222
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.40(a)Document review, approval documentation
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