Smith & Nephew Hit With Warning Letter Over Morcellators
May 7, 2015
The FDA warning letter involves the London-based multinational's Andover, MA, plant, and brings up a number of issues.
Nancy Crotti
FDA has issued a warning letter to Smith & Nephew, citing inadequate quality control measures with the Truclear Ultra 4.0 Reciprocating Morcellators made at its Andover, MA, plant.
Following a March inspection of the facility, FDA concluded that the company couldn't prove it had corrected issues regarding complaints of loss of visualization with the morcellators and about the devices' sluff chambers being too small.
FDA also claimed the plant violated company procedures by releasing morcellators it had put on product hold in 2012 before completing a health hazard assessment. The company also released "reworked" reciprocating morcellators without evaluating the effects of ethylene oxide sterilization on the devices, the letter said.
An April 16, 2015, a company response to FDA said the morcellators were on hold.
The agency said Smith & Nephew failed to:
Prove it had changed a translation of "non-absorbable suture" to "absorbable suture" in instructions for its TwinFix Ultra Preloaded Suture Anchors;
Address "a large number of complaints that had been open for greater than 90 days;"
Address complaints about Beaver Blade breakage. The company website says the disposable blades are used in hip surgery;
Conduct quality audits in the third and fourth quarters of 2014. The letter also says the company allowed employees responsible for particular areas to audit those areas in Q4 2013 and Q2 2014. The company plans to re-audit four areas, and have an outside expert assess the audits' effectiveness, the letter said.
FDA warned the company to correct the alleged violations or face the consequences.
"Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice," it said. "These actions include, but are not limited to, seizure, injunction, and civil money penalties."
London-based Smith & Nephew said the following in an email response to Qmed:
"We are currently drafting a response and are committed to working with the FDA to resolve all of the issues identified. There have been no issued field actions, recalls, or seizures demanded by FDA as a result of the 483 observations and/or Warning Letter. We are confident that the necessary actions are underway to deliver these improvements."
Nancy Crotti is a contributor to Qmed and MPMN.
Like what you're reading? Subscribe to our daily e-newsletter.
About the Author
You May Also Like