The FDA hit Smith & Nephew with a warning letter for quality, CAPA and procedural issues related to its Truclear Ultra Reciprocating Morcellators 4.0.
The devicemaker placed a voluntary hold on shipments of the morcellators following a March 26 Form 483. The product will remain on hold until Smith & Nephew completes its enhancement of quality systems documentation for the product, company spokesman Joe Metzger tells IDDM.
During a March 4-26 inspection of the firm’s Andover, Mass., facility, investigators cited failure to establish and maintain procedures for verifying or validating corrective and preventive actions following complaints of loss of visualization when using the Truclear Ultra Reciprocating Morcellators. Eight corrective action reports reviewed during the inspection lacked sufficient information to ensure the issue was resolved, the April 30 says.
Smith & Nephew continues to receive complaints about the product more than two years after a review began in September 2012. The company placed a hold on the morcellator in August of that year, but it was removed before the review of the complaints was completed — a violation of the firm’s procedures.
Other violations observed during the inspection included failure to establish procedures to control nonconforming product, failure to establish and maintain procedures to verify device design, and failure to establish procedures quality audits.
The FDA asked for an update regarding improvements Smith & Nephew is making to its CAPA system, including having a quality manager oversee the revised system. Metzger says the company is working with the FDA to resolve all issues.
There have been no FDA-issued field actions, recalls or seizures as a result of the warning letter, he says.