FDA Inspection
Phoenix Thera-Lase Systems LLCPhoenix Thera-Lase Systems LLC – FDA Inspection, Jun 3, 2024
Record Details
This FDA Inspection record concerns Phoenix Thera-Lase Systems LLC, with an inspection on June 3, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 193c2e51-3958-4f75-be2a-0a79eb34338f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1230528
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
18- 21 CFR 1040.10(g)(3)Class IV "Danger" label
- 21 CFR 1010.2(a)Lack of certification of conformance
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 1010.2(b)Certification label or tag
- 21 CFR 1010.3(a)ID label or tag
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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