The FDA warned Insightra Medical last month about how it handles reporting and investigating failure complaints concerning its intra-aortic balloon catheters. An FDA investigator inspected Insightra’s Irvine, Calif., facility in February and issued a Form 483 detailing the company’s failure to adequately establish procedures for receiving, reviewing, and evaluating complaints, according to a May 21 […]
Warning Letter
FDA warns Signal Medical on unapproved hip implants
FDA warns on Hospira pumps after researcher reveals security flaws
FDA warns Smith & Nephew on Truclear Ultra morcellator
FDA closes out CryoLife warning letter, PerClot trial launches
FDA bars Stanmore Implants from U.S. market
The FDA slapped Stanmore Implants with an import ban until the British orthopedic implant maker deals with problems flagged in a warning letter from the federal safety watchdog.
Another FDA warning letter for Hospira
FDA warns Staar Surgical again over California plant
Staar Surgical (NSDQ:STAA) said yesterday that it received another warning from the FDA over documentation problems at its plant in Monrovia, Calif.
Getinge shares jump on FDA deal
FDA officially clears Integra’s Puerto Rico plant
FDA warns Cook Medical on ‘nonconformance’ issues
The FDA today released a warning letter it sent to Cook Medical last month, flagging problems found during inspections of a Bloomington, Ind., plant last summer.