Lucero Medical, maker of the Enduramesh Corpectomy Spacer System, lacks design validation for the device, despite implantation of 89 of the vertebral body replacement systems by the time of an FDA inspection, according to a recent Form 483. Read More

GE Medical Systems received a post-inspection Form 483 after failing to create a CAPA record for an observation from a previous inspection. Read More

While all FDA device investigators go through specialized training, combination products and foreign inspections can still pose challenges during the inspection process. Read More

The FDA will soon begin identifying candidates for a pilot program that will let manufacturers self-identify and correct possible regulatory violations to avoid FDA inspection. Read More

Last year was a key year for advancements in device supply chain transparency, with the FDA’s September release of its final unique device identification rule. Read More

Sharplight Technologies, an Israeli maker of powered surgical lasers, received an FDA warning letter for failures with quality records and other documents. Read More

The FDA will soon begin identifying candidates for a pilot program whereby manufacturers can opt to self-identify and correct possible regulatory violations and avoid FDA inspection. Read More

San Up, a Buenos Aires maker of piston and ultrasonic nebulizers, was warned by the FDA after cleaning shortfalls and other good manufacturing practice slip-ups. Read More