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The FDA rapped three devicemakers for a variety of violations including complaint handling, validations and failure to establish procedures for process changes. Read More
The FDA cited Carol Cole Company for failure to submit timely medical device reports of its devices that use microcurrents to tone, firm and reduce wrinkles, according to a Form 483 that was issued following a March 20-22 inspection of the firm’s Vista, Calif. facility. Read More
Process validation failures, documentation lapses and failure to establish corrective and preventive actions were just a few of the quality lapses found during a March 15-19 inspection of International Hospital Products’ Littleton, Colorado facility. Read More