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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
In a rare exception to the FDA’s normal practice, the agency 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
A devicemaker’s manufacturing facility in Oregon was cited for closing customer complaint investigations without documenting the changes identified for addressing the issues or verifying their effectiveness. 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
At least three complaint cases evaluated by the FDA lacked the required root cause investigations or rationale for not initiating investigations. Read More
Light Age, a New Jersey-based manufacturer of class II medical lasers, drew an FDA warning letter for 12 different violations flagged during a fall 2017 site inspection. Read More
The firm’s device history records were found to be incomplete, missing required information such as primary identification labeling for each production unit. Read More
An FDA inspection at a medical device facility in Akita, Japan revealed nonconformities with process and software validation, as well as complaint handling and device history records. Read More
GMP violations revealed during an FDA inspection include a lack of written procedures for design control, CAPA actions, and complaint handling. Read More