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None of the company’s complaints from 2016 or 2017 reviewed by the FDA had been evaluated to determine whether they should be reported to the agency as adverse events. Read More
Westone Laboratories’ manufacturing facility in Oregon drew a Form 483 from the FDA for significant quality system nonconformities and equipment calibration issues. Read More
Palo Alto Health Sciences drew a Form 483 from the FDA for inadequate CAPA and complaint procedures, and for incomplete internal auditing and supplier profiles. Read More
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