Integra LifeSciences (NSDQ:IART) today revealed its receipt of a warning letter sent by the FDA last week about quality system issues at a Boston-area plant that makes products to treat chronic wounds. Plainsboro, N.J.-based Integra said the FDA inspected the plant last October and November, resulting in a Form 483 covering the problems found there. […]
Warning Letter
FDA warns Medtronic on CRM plants in Minnesota, Puerto Rico
The FDA this week released warning letters it sent to Medtronic (NYSE:MDT) over issues with cardiac rhythm management plants in Minnesota and Puerto Rico. The federal safety watchdog said inspections in April and May at both plants turned up problems related to the recall of CRM devices over high-voltage arcing, which led to the recall […]
FDA releases Zimmer Biomet warning letter
The FDA yesterday released the warning letter it sent last week to Zimmer Biomet (NYSE:ZBH) over quality violations found during 2016 and 2018 inspections at a plant in Warsaw, Ind. Zimmer revealed its receipt of the August 24 letter earlier this week, saying it doesn’t expect to take a material hit from resolving the issues flagged in […]
Zimmer Biomet reveals FDA warning letter for Indiana plant
Zimmer Biomet (NYSE:ZBH) today said it received a warning letter last week from the FDA about a plant in its home base of Warsaw, Ind., over quality violations found during a 2016 inspection. The FDA inspected the North Campus location in Warsaw just before Thanksgiving 2016, documenting numerous violations in a Form 483. The company’s lengthy […]
FDA lifts Staar Surgical warning letter
Staar Surgical (NSDQ:STAA) said today that the FDA lifted a 2014 warning letter issued over design and quality issues at a plant in California. Inspections by the federal safety watchdog that year turned up 15 issues at the plant in Monrovia where the company makes its intraocular lenses. The warning letter cited missing design files for […]
FDA warns Magellan Diagnostics on lead tests
The FDA today warned Meridian Bioscience (NSDQ:VIVO) subsidiary Magellan Diagnostics based on the Class I recall of its lead poisoning tests, accusing the company of failing to protect patients after it learned of problems with the tests. The May recall, which was expanded in July, involves Magellan’s LeadCare, LeadCare II, Ultra and Plus products. The tests may underestimate blood lead levels […]
FDA warns Entellus Medical over Xpress sinus dilator pediatric trial
The FDA sent a warning letter to Entellus Medical (NSDQ:ENTL) over its failure to prevent physicians from violating the approved protocol for a pediatric trial of its Xpress sinus dilator. The April 6 letter, published online this week by the federal safety watchdog, stems from an inspection that began exactly a year ago of a […]
FDA lifts warning letter on Zimmer Biomet plant in China
Zimmer Biomet (NYSE:ZBH) said today that the FDA closed out a 2015 warning letter over problems at a subsidiary’s plant in China. The June 3, 2015 letter flagged 5 violations found during inspections of the Zhejiang Biomet Medical Products plant in Jinhua City, Zhejiang, following inspections of January of that year. The federal safety watchdog closed the matter […]
FDA lifts warning letter on Masimo plant in California
Masimo (NSDQ:MASI) said today that the FDA lifted a 2014 warning letter issued over procedures at the Irvine, Calif., plant that makes its Pronto 7 pulse oximeters. The federal safety watchdog sent the letter in August 2014 after inspections in August to October 2013, flagging Masimo for failing to “review, evaluate, and investigate complaints involving the possible […]
FDA warns Abbott on St. Jude Medical plant in California
The FDA yesterday issued another warning letter about a St. Jude Medical (NYSE:STJ) plant in California, now owned by Abbott (NYSE:ABT), that makes cardiac rhythm management products. It’s at least the 2nd time the federal safety watchdog has flagged the plant in Sylmar, which makes defibrillators and the Merlin home cardiac monitor. In 2012 the FDA slapped St. […]
FDA sends warning letters to 12 medical device companies
The FDA today published the warning letters it sent recently to 12 medical device companies in the U.S. and overseas for violations found during recent inspections. The federal safety watchdog’s inspectors found a variety of problems at the companies’ plants, ranging from inadequate design control procedures to problems with the way they track and report adverse […]
