FDA Inspection
Omega Laser SystemsOmega Laser Systems – FDA Inspection, Sep 10, 2015
Record Details
This FDA Inspection record concerns Omega Laser Systems, with an inspection on September 10, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Omega Laser Systems
- Inspection Date
- September 10, 2015
- Product Type
- Devices
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ID · 4b3b1546-1d31-421f-a361-47435f46aa1c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 944843
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.80(e)Documentation
- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - software validation not performed
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