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The firm’s device history records for its recalled lots did not include the final quantity of products reviewed, approved and released for distribution. Read More
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