The FDA posted 15 new warning letters to device manufacturers on its website Aug. 16 for GMP violations under the quality system regulation. Fourteen of those letters went to foreign manufacturers and one went to a domestic company. Read More
The FDA is citing three pharmaceutical firms for a litany of GMP violations that range from data integrity discrepancies to laboratory control deficiencies. Read More
Spanish regulators want to temporarily suspend a laboratory’s EU certificate over a host of GMP deficiencies found at its facility. Read More
The EMA is trying to simplify data integrity compliance by compiling all of its expectations into a single document that covers the entire data integrity lifecycle. Read More
Over the past few years, poor supplier controls remain one of the top five FDA citations for device manufacturers. Read More
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