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The FDA slapped Sollentuna, Sweden-based MKL Diagnostics with a warning letter for failing to have a design control procedure for its Phadebact test kits. Read More
Cook Medical is under pressure from the FDA to fix sweeping quality problems at its Indiana facility relating to how the devicemaker addressed more than 735,000 manufacturing nonconformances over a two-year period. Read More
Using QSIT for internal audits could put devicemakers in a much stronger position when FDA investigators coming knocking on the door, compliance experts agree. Read More
Devicemakers have a better shot at emerging from an FDA inspection unscathed if they watch for common investigator tactics, such as stepping away from the company contact, an expert says. Read More
Greiner Bio One Brasil Produtos ran afoul of the FDA after documenting design changes in informal meetings with informal notes, a recent warning letter shows. Read More
Navilyst Medical, a subsidiary of AngioDynamics, received an FDA warning letter for quality issues at two facilities, including the sale of sterile product that contained foreign matter such as hair. Read More
International medical device regulators are trying to entice more companies to participate in a single-audit pilot program, promising they will receive no warning letters unless there is an immediate threat to public health. Read More
The FDA has requested a meeting with Express Diagnostics International, as well as an independent audit of the company’s manufacturing practices, following an inspection that uncovered problems with testing and labeling of the company’s products. Read More
The FDA slapped Sollentuna, Sweden-based MKL Diagnostics with a warning letter for failing to have a design control procedure for its Phadebact test kits. Read More
Devicemakers have a better shot at emerging from an FDA inspection unscathed if they watch for common investigator tactics, such as stepping away from the company contact, an expert says. Read More
The FDA slapped Mani Hanoi, a Vietnam maker of surgical sutures with attached needles, with a warning letter for particle monitoring slips and other GMP issues. Read More