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The FDA posted a Form 483 flagging several GMP and MDR nonconformities — most of which are repeat observations — at a Zimmer Biomet medical device manufacturing facility in Indiana. Read More
The firm’s CAPA procedures and lack of written MDR procedures were among the nonconformities flagged on more than one occasion after FDA inspections. Read More
The FDA issued a Form 483 flagging several GMP and MDR nonconformities — most of which are repeat observations — at a Zimmer Biomet medical device manufacturing facility in Indiana. Read More
CDRH is looking to enroll a total of nine participants in its new pilot program aimed at identifying best practices for quality product manufacturing. Read More
Facilities in India, Lithuania and Texas drew warnings from the FDA for a variety of noncompliances, including inadequate validations, designs and device history records. Read More
CDRH is looking to enroll a total of nine participants in its new pilot program aimed at identifying best practices for quality product manufacturing. Read More
Hand Biomechanics Lab, a manufacturer of bone fixation fastener systems in Sacramento, California, was hit with an FDA warning letter for failing to submit MDRs and for GMP nonconformities. Read More
Facilities in India, Lithuania and Texas drew warnings from the FDA for a variety of noncompliances, including inadequate device history records. Read More
The firm’s device history records for its recalled lots did not include the final quantity of products reviewed, approved and released for distribution. Read More
The FDA warned three devicemakers in Germany, The Netherlands and the U.S. for GMP and other violations, including inadequate responses to a Form 483 report. Read More
The California company received complaints about patients who required prescription antibiotics for pin site infections developed while being treated with the Digit Widget device. Read More
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