Investigators found the facility’s complaint procedures did not include evaluating complaints to determine if an investigation was needed. Read More

Medical device quality managers that don’t want to wind up a statistic in a future FDA report on quality deviations should dig deeply into the agency’s recently released report on inspections, Form 483s and warning letters, says Michael Gaba, a partner in the law firm Polsinelli. Read More

In a decision associated with the United Kingdom’s withdrawal from the European Union, the UK’s Medicines & Healthcare products Regulatory Agency issued updated guidance with new links to notified bodies permitted to undertake conformity assessments of medical devices in the UK. Read More

India’s Ministry of Health and Family Welfare has revised the acceptance criteria for in vitro diagnostic devices to detect HIV, HBsAg and HCV. Read More

The FDA cited Jensen Industries, Tyson Bioresearch, OsteoSymbionics and Innovative Sterilization Techniques over problems with their CAPA procedures, complaint handling and MDRs. Read More

The FDA’s observations primarily focused on CAPA issues and record-keeping. Read More