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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
Faced with long waits for Brazilian good manufacturing practice certificates, some devicemakers are turning to the courts to speed up product registrations — and seeing their time to market cut in half, an expert says. Read More
An FDA investigator handed Chase Medical a Form 483 after the company’s manufacturing assembler admitted she does not always remember to document all in-process tests for the Tripod Heart Stabilizer devices. Read More