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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
The firm promoted several intended uses for the devices, such as for endometriosis and Crohn’s diseases, that have not been evaluated by the FDA. Read More
The FDA flagged device firms in the U.S., Germany, the United Kingdom, the Czech republic, and India for a range of issues, including MDR reports, CAPA failures and other GMP issues. Read More
A company that manufactures and repackages solutions used in kidney dialysis was cited by the FDA for selling products that failed quality tests and had not been cleared in reinspections before shipping, according to a warning letter from the agency. Read More
The FDA issued a warning letter to Euro-Diagnostica in Malmo, Sweden for its complaint and CAPA procedures as well as its quality audits, and said the company’s responses to observations from a January inspection were inadequate. Read More