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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 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
Sharplight Technologies, an Israeli maker of powered surgical lasers, received an FDA warning letter for failures with quality records and other documents. 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
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
The FDA has created a new Division of International Compliance Operations to oversee inspections of foreign devicemakers and the international audit program. Read More
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
An FDA review of Mectra Labs’ website found that the company was offering a new size of its MAGI and ALIEN insufflation needles without clearance or approval, prompting a warning letter. Read More