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The FDA has cited three device firms for a range of compliance issues including inadequate design and device validation procedures as well as inadequate procedures for receiving, reviewing and evaluating complaints. Read More
The FDA has issued a warning letter to Abbott citing serious CAPA and other violations at its St. Jude Medical defibrillator manufacturing facility in Sylmar, Calif. Read More
The FDA has cited four device firms for a range of compliance issues including inadequate test methods, production controls, and CAPA procedures. Read More
The most common error companies make when conducting internal audits is to take a confrontational approach when fixing them, according to one compliance expert. Read More
Lusys Laboratories in San Diego, Calif., failed to establish design control procedures and ensure that equipment met specifications, the FDA said, in a Form 483. Read More
Isolux received a Form 483 for not adequately establishing procedures for quality audits, for not implementing a supplier evaluation procedure, and other observations. Read More