ITG-Medev failed to follow up on its promised solutions to nonconforming process validations and documentation of acceptance activities, the FDA said in a warning letter to the devicemaker. Read More
AdvaMed and other industry groups asked the FDA to provide more details on the agency’s proposed list of alternative mechanisms for compliance with CGMP requirements for combination products. Read More
Numerous quality system failures were uncovered at South Korea’s Mi Gwang Contact Lens Company during a March 2018 FDA inspection. Read More
Devicemaker Graphic Controls Acquisition lacked numerous procedures to ensure that products conformed to specifications, according to a 483 the firm received following a May 8 -14 inspection of its Buffalo, New York facility. Read More
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