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Synecco, a China-based contract manufacturer and contract sterilizer, received an FDA warning letter for shortfalls in sterilization validation and other GMP issues. 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
At the close of a comment period on the quality management systems reporting burden for devicemakers, the FDA received just one reply requesting a few clarifications. Read More
CAPA shortfalls identified during an FDA inspection in late August and September led to a recent Form 483 for Teleflex Medical. Among noted deviations, the company did not evaluate whether it should initiate a CAPA for distributed humidifier adaptor devices with seal defects. Read More
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
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
The FDA’s final guidance on unique device identification should allow for submission of UDI data elements within 10 days of commercializing a device, rather than requiring that they be in the Global UDI Database before market launch, as the stricter requirement could lead to lost sales, AdvaMed says. Read More