FDA Inspection
T-MED SRLT-MED SRL – FDA Inspection, Mar 16, 2023
Record Details
This FDA Inspection record concerns T-MED SRL, with an inspection on March 16, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d7d5e887-3ba6-4ccc-b519-d090e4877702
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1200411
- 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 820.75(a)Lack of or inadequate process validation
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