FDA Inspection
USA Medical, LLCUSA Medical, LLC – FDA Inspection, Mar 15, 2022
Record Details
This FDA Inspection record concerns USA Medical, LLC, with an inspection on March 15, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- USA Medical, LLC
- Inspection Date
- March 15, 2022
- Product Type
- Devices
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ID · 52b8159c-6935-445f-aae8-78b4b0c59149
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1164970
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Enforcement
- Warning Letter
FDA Citations
13- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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