FDA Inspection
Inova Lasers LLCInova Lasers LLC – FDA Inspection, Feb 7, 2020
Record Details
This FDA Inspection record concerns Inova Lasers LLC, with an inspection on February 7, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Inova Lasers LLC
- Inspection Date
- February 7, 2020
- Product Type
- Devices
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ID · 1e5e1fc7-d576-4aef-8f82-6088c1fe1598
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1117377
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
11- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 1010.2(b)Certification label or tag
- 21 CFR 1010.3(a)(2)ID label lacks place, month & year of manufacture
- 21 CFR 1010.2(c)Certification not based on adequate test/testing program
- 21 CFR 1040.10(g)(3)Class IV "Danger" label
- 21 CFR 1040.10(f)(4)Key control
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 1040.11(a)(2)Calibration of measurement system
- 21 CFR 803.17Lack of Written MDR Procedures
Showing 10 of 11 citations.
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Other FDA inspections of Inova Lasers LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Inova Lasers LLC
- FDA Inspection 1152925 - 2021-09-17
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