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Responses to internal audit reports are critical for GMP compliance because they fall under CAPA — so how a company responds to the findings of an internal audit is a key component of an effective audit. Read More
The FDA issued warning letters to four medical device firms citing serious CAPA and other violations, including inadequate complaint response, quality testing, and verification of shipping and packaging methods to ensure product integrity and sterility. Read More
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