Smith & Nephew Receive FDA Warning Letter Regarding Quality Control Issues

Spinal Tech

The Food and Drug Administration recently issued a letter of warning to Smith & Nephew over manufacturing problems at a company plant in Tuttlingen, Germany, according to a Bloomberg Businessweek report.

During a July visit to the hip replacement manufacturing plant, German inspectors cited the company for multiple quality control problems. Smith & Nephew failed to document several production steps, including quality tests and corrections to device parts manufactured at the plant, according to the letter.

The FDA's letter said that the company's August response to the citations was inadequate and now asks the company to respond to their letter within 15 business days with an outline of a plan to correct the problems.

Read the Bloomberg Businessweek report on Smith & Nephew.

Read other coverage on Smith & Nephew:

- Smith & Nephew Adds 100 Employees

- Smith & Nephew CEO Speaks About Orthopedic Device Environment

- Court Rules in Favor of Smith & Nephew in Patent Litigation

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Webinars

Featured Whitepapers