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Serious quality system deficiencies that were repeat violations from a 2015 inspection landed Korean devicemaker Won Industry an FDA warning letter following an inspection of its Siheung-si, South Korea facility. Read More
The FDA hit Phoenix, Arizona-based devicemaker CPAPNEA Medical Supply with a warning letter for marketing a device without premarket approval. Read More
Rhode Island device manufacturer Unetixs Vascular drew an FDA warning letter for failing to meet design requirements for its MultiLab Series ROODRA vascular diagnostic system. Read More
Devicemaker Transfer Technology racked up a 12-item Form 483 covering a multitude of quality management issues following an FDA inspection of its Huntington Beach, California facility. Read More
Medegen Medical Products was cited for validation lapses and failure to control nonconforming product following an FDA inspection of its Gallaway, Tennessee plant. Read More
Labeling failures and validation lapses were among the quality system lapses uncovered during an FDA inspection of CDB Corp.’s Leland, North Carolina facility. Read More
Serious quality system deficiencies that were repeat violations from a 2015 inspection landed Korean devicemaker Won Industry an FDA warning letter following an inspection of its Siheung-si, South Korea facility. Read More