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With the FDA’s foreign inspections on hold through April due to the coronavirus outbreak, the agency is doing “anything and everything” to make use of international regulators to keep inspections going, according to a senior agency official. Read More
Failure to establish corrective and preventive actions procedures and systems for receiving, reviewing and evaluating complaints landed devicemaker Oxus a 483 following an inspection of its Auburn Hills, Michigan facility. Read More
Biomedix WAI’s process validation procedures didn’t ensure that products would consistently meet specifications, an FDA inspection of the firm’s Bloomington, Indiana facility found. Read More
Failure to maintain complaints and submit medical device reports to the FDA, among other serious quality failures, landed devicemaker Ortho Solutions DBA DynaFlex a Form 483 following an FDA inspection of its Saint Ann, Missouri plant. 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
The FDA hit Phoenix, Arizona-based devicemaker CPAPNEA Medical Supply with a warning letter for marketing a device without premarket approval. Read More