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Stryker Neurovascular drew a Form 483 for failing to maintain complaint files and failing to file medical device reports, among other violations. Read More
The firm’s CAPA procedure failed to ensure that the information gathered about nonconforming products and quality issues reached the person responsible for dealing with them. 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
The FDA flagged almost a dozen devicemakers for noncompliances observed during agency inspections, including inadequate medical device reporting. 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
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