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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
No documentation was found indicating that the firm followed up to obtain missing or additional information or issued a device recall that would have aided in the investigation. Read More
FDA inspection reports consistently show that the corrective and preventive action process is the biggest inspection problem for medical device facilities. And those who have to implement CAPAs have plenty of questions about how best to manage them. Read More
The FDA issued a warning to Florida-based ProSun International over significant GMP and branding violations revealed during an August inspection. Read More
The FDA flagged five devicemakers for a variety of noncompliances observed during inspections, including inadequate CAPA procedures, and failure to properly investigate complaints. 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
CME America failed to include revisions made to its manufacturing operations in its device master record for the BodyGuard 323 Infusion Pump, according to a Form 483. Read More
The firm’s complaint procedure was found to be inadequate in that it lacked provisions for conducting a review of complaints to determine whether an MDR was required. Read More
An agency investigator found three complaints regarding devices that were returned to Cadwell more than a year ago that had not been evaluated. Read More