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Production workers at ATS Manufacturing threw out all of the nonconforming products they found and failed to document any follow-up activities over the course of nearly four years, an FDA investigator discovered in an August 14-18 inspection. Read More
The FDA warned investigational medical device sponsor UVLrx Therapeutics for eight violations an FDA investigator observed during an inspection of its Florida facility from March 27 through April 4. Read More
As the compliance deadline of Jan. 1, 2019 approaches for Canadian manufacturers, the consortium is exploring other ways to improve the program’s efficiency. Read More
An inspection in March by the FDA of ELITech Group’s facility in Spankeren, The Netherlands prompted a warning letter after the device manufacturer failed to follow through with the promises made in response to a Form 483 report. Read More
Inadequate processes for validating the facility’s water system, controlling purchased products and accepting incoming products were some of the issues flagged. Read More
A CAPA report showed manufacturing errors that led to many low patient results were caused by a failure to update manufacturing procedures after a design change, the agency said. Read More
An inspection in March by the FDA of ELITech Group’s facility in Spankeren, The Netherlands prompted a warning letter after the device manufacturer failed to follow through with the promises made in response to a Form 483 report. Read More
The FDA sent an Oct. 23 warning letter to Magellan Diagnostics as part of an ongoing investigation based on data showing its blood lead testing systems provided false results. Read More
Devicemaker Kelyniam Global drew a warning letter from the FDA after failing to adequately address numerous GMP issues observed in a May inspection of its Canton, Connecticut facility, including the manufacturing of unapproved implants. Read More
The FDA cited a German medical device manufacturer for noncompliance issues related to MDR reports, complaint handling, as well as device master records and history records. Read More