# FDA 483 - Gecko Labs, LLC - December 14, 2023

Source: https://www.keypedia.com/records/483/gecko-labs-llc/b5461501-a912-4fab-8366-988868d5a508

> FDA 483 for Gecko Labs, LLC on December 14, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gecko Labs, LLC
- Inspection Date: 2023-12-14
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Officers

- [Juanj Wu](https://www.keypedia.com/people/juanj-wu/0d3e8970-b524-49f6-a307-079091b3c91d)

Company: https://www.keypedia.com/companies/gecko-labs-llc/925185a6-3623-4718-96a2-420f6b800859

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6