FDA Inspection
RESTECH, dba Mederi RF LLCRESTECH, dba Mederi RF LLC – FDA Inspection, Sep 18, 2024
Record Details
This FDA Inspection record concerns RESTECH, dba Mederi RF LLC, with an inspection on September 18, 2024, issued by the Dallas District Office, covering medical devices & rad health.
- Company
- RESTECH, dba Mederi RF LLC
- Inspection Date
- September 18, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 8857019a-3d93-43c0-9bee-5dac2f4e4e27
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1249477
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - software validation not performed
- 21 CFR 820.30(h)Incorrect translation to production specifications
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(i)Software validation for automated processes
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