FDA Inspection
Gecko Labs, LLCGecko Labs, LLC – FDA Inspection, Dec 14, 2023
Record Details
This FDA Inspection record concerns Gecko Labs, LLC, with an inspection on December 14, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7c0325fe-afa3-4851-9f5b-988e9060ca07
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1225069
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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