FDA Inspection
Centre Light Solutions, LLCCentre Light Solutions, LLC – FDA Inspection, May 30, 2018
Record Details
This FDA Inspection record concerns Centre Light Solutions, LLC, with an inspection on May 30, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f7293a21-050e-4a8a-9b73-ff86da944a42
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1054686
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 803.17Lack of Written MDR Procedures
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