# FDA WARNING_LETTER - Lusys Laboratories, Inc. - September 24, 2021

Source: https://www.keypedia.com/records/warning_letter/lusys-laboratories-inc/5b81b74e-a5c5-4a73-98ec-969d6153265a

> FDA WARNING_LETTER for Lusys Laboratories, Inc. on September 24, 2021. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Lusys Laboratories, Inc.
- Inspection Date: 2021-09-24
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On February 17, 2022, the FDA issued a Warning Letter to Lusys Laboratories, Inc. following an inspection from September 13-24, 2021, at their San Diego facility. The inspection revealed that Lusys Laboratories, Inc. manufactures and distributes COVID-19 IgG/IgM Antibody Test and COVID-19 Viral Antigen Test kits in the United States.

The FDA determined these COVID-19 Test Kits are medical devices intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. The products were found to be adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because they were distributed without required marketing approval, clearance, or authorization (PMA or IDE). They were also deemed misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), for failure to notify the FDA of intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

The introduction or delivery of these products into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S

## Related Documents

- [WARNING_LETTER - 2015-05-15](https://www.keypedia.com/records/warning_letter/lusys-laboratories-inc/8f44cfc5-6e7b-4d05-a605-2a283cf063c1)
- [483 - 2021-09-24](https://www.keypedia.com/records/483/lusys-laboratories-inc/e6a45b80-b07f-4380-b023-468bd7142dd6)

## Related Officers

- [Director](https://www.keypedia.com/people/timothy-t-stenzel/c53bdcbc-5f38-4c82-b8fc-181624201c10)

Company: https://www.keypedia.com/companies/lusys-laboratories-inc/348b7ce4-cdf8-44e0-abf5-ff62a64182ac

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7