483
Gecko Labs, LLCFDA 483 - Gecko Labs, LLC - December 14, 2023
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Record Details
Gecko Labs, LLC in Poway, CA, was inspected by the FDA, revealing significant deficiencies in their quality system. The inspection found issues with device history records, complaint handling procedures, and equipment maintenance, indicating a lack of established and followed procedures. These findings suggest a moderate level of non-compliance with regulatory requirements for medical device manufacturers.
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ID · b5461501-a912-4fab-8366-988868d5a508