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A California photographic equipment company failed to file a required report with the FDA about a modification made to a camera to reduce a health risk in response to a customer complaint, the agency said in a Form 483 report. Read More
FDA officials welcomed a risk-based approach to CAPA systems during a session at 2017 RAPS Regulatory Convergence, but cautioned that each CAPA investigation is unique. Read More
The FDA issued warning letters to five device manufacturers for a range of issues, including a failure to seek pre-market approval, to apply for modified intended uses, and quality violations. Read More
A company that manufactures EpiPens neglected to follow up on hundreds of complaints that the epinephrine injectors failed to operate during life-threatening emergencies, including some that resulted in patients’ deaths — and the company did not recall potentially defective injectors from the marketplace even after identifying a fault in a critical injector component, the FDA said in a warning letter. Read More
The FDA flagged several U.S. and international facilities for a range of deviations including inadequate complaint procedures, MDR reporting, and recordkeeping. Read More