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The FDA cited eight device firms for a range of compliance issues including inadequate complaint procedures, lack of written quality procedures, shipping products prior to approval, inadequate documentation, and unreported software changes. Read More
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
South Africa’s Medicines Control Council (MCC) released a draft guideline listing minimum requirements for quality manuals that medical device importers, manufacturers, distributers, exporters, and wholesalers must maintain. 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
Congress reached a deal on a comprehensive, 1,600-page bill to fund the federal government through September 30 – and give the FDA an extra $39 million. Read More