FDA 483 - Lusys Laboratories, Inc. - September 24, 2021

Lusys Laboratories, Inc. in San Diego, CA, received a Form 483 with four observations during an FDA inspection. The firm was cited for failing to validate manufacturing processes for COVID-19 test strips and for not establishing adequate procedures to control environmental conditions for finished products. Additionally, the inspection revealed deficiencies in the firm's corrective and preventive action (CAPA) system and a failure to maintain complete distribution records for medical devices.