FDA Uncovers Quality Control Problems at Smith & Nephew Facility

Executives with Smith & Nephew Plc are working with the U.S. Food and Drug Administration (FDA) to address the agency’s concerns about quality control procedures at its German manufacturing plant.

FDA inspectors discovered problems with the sterilization of hip implant components at the company’s plant in Tuttlingen, Germany, during a visit in mid-July, according to a Dec. 21 warning letter posted on the agency’s website. During that summer visit, inspectors also noticed that Smith & Nephew did not perform certain necessary tests.

In addition, the FDA found fault with the company’s response to the problems.

Smith & Nephew spokeswoman Liz Hewitt told Bloomberg that new sterilization procedures have been implemented since the FDA’s inspection, and the company has been working with the agency since the summer to address the agency’s concerns. She said the warning letter would not effect customers or the supply of hip implants because the company also manufactures parts at plants in Memphis, Tenn., and Warwick, England.

Hewitt also claimed the company had not yet received the FDA’s warning letter. Upon receipt, Smith & Nephew will have 15 days to respond. The FDA has said it will conduct another inspection to ensure changes have been made in quality control procedures at the German manufacturing plant.