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The firm’s CAPA procedures at the time of the FDA site inspection did not include processes for analyzing quality data that could help to identify any issue other than nonconforming product. 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
Facilities in India, Lithuania and Texas drew warnings from the FDA for a variety of noncompliances, including inadequate device history records. Read More
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