FDA Cites Lusys Labs for Design Control, Other Procedures

Lusys Laboratories in San Diego, Calif., failed to establish design control procedures and ensure that equipment met specifications, the FDA said, in a Form 483.

An inspection of the company’s San Diego, Calif., facility in October through December 2016 revealed that the company had not established design control procedures for several of its Zika virus tests, FSH one-stop menopause test, and in vitro diagnostic devices.

Lusys also failed to provide documentation of design control activities to justify the data used to support the expiration dates for finished IVDs.

The inspector further observed that certain equipment was not shown to meet specifications. In addition, the facility had inadequate procedures for acceptance of in-process and finished IVDs.