Steris Corp.' s Complaint Handling System, QS Violations Cited By FDA
This article was originally published in The Gray Sheet
Executive Summary
Steris Corporation failed to report or adequately determine the cause of several adverse events involving the Steris System 1 processor and Quick Connect Kit accessories, FDA contends in a Dec. 9 warning letter to the company.
You may also be interested in...
Endoscope public health advisory
Inconsistencies between reprocessing instructions provided by an automated endoscope reprocessessor (AER) manufacturer and the maker of a reusable bronchoscope device apparently led to several incidents in which patients developed serious infections after undergoing a bronchoscope examination, FDA and the Centers for Disease Control and Prevention state in a Sept. 10 public health advisory. In addition, "bronchoscopes were inadequately reprocessed when inappropriate channel connectors were used with the AER," according to the statement
Beauty Packaging Producers: July Marks Registration Deadline With PRO In Three States
Companies considered producers of single-use packaging in Oregon, Colorado and California must register with Circular Action Alliance, the leading (and currently only) producer responsibility organization, by 1 July 2024 under new state recycling laws.
Metsera Launches As New Obesity Contender Flush With $290m
Clive Meanwell, former CEO of The Medicines Company, will helm the new company, backed by ARCH and other investors. He talked to Scrip about the new venture.