FDA Issues Warning to Orthopedic Implant Manufacturer

Warning to orthopedic implant manufacturer

WASHINGTON, D.C. — The United States Food and Drug Administration issued a stern warning to orthopedic implant manufacturer Orchid Orthopedic Solutions regarding failures of the company’s quality control systems including the method in which the company investigates and resolves consumer complaints. The Regulatory Affairs Professional Society reported that the FDA sent Orchid Orthopedic Solutions a strongly worded warning letter that outlined six violations of FDA regulations. The letter comes after FDA investigators conducted a 12-day inspection of Orchid Orthopedic Solutions’ facilities in February of 2019.  The company’s primary manufacturing plant is located in Farmington Hills, Michigan.

In its letter, the FDA alleges that Orchid Orthopedic Solutions failed to clean the implant materials properly, failed to implement corrective actions and preventative actions, and found the company’s method of conducting quality audits inadequate. Furthermore, the FDA determined that Orchid Orthopedic Solutions’ procedure for resolving customer complaints inadequate.

The FDA alleged in its most recent warning letter that Orchid Orthopedics Solutions failed to respond timely to complaints. The FDA cited three egregious examples. The firm delayed investigating one complaint of tensile test strength failure and a complaint concerning contaminated coating for over 150 days. In the last instance, the firm denoted a complaint about non-uniform coating resolved 158 days after the company received the consumer complaint. The FDA deemed these slow responses wholly inadequate.

The FDA plans to re-inspect the company’s Farmington Hills facility. Orchid Orthopedic Solutions replied to the FDA in March and in April addressing concerns the agency raised previously. The FDA said that it must verify the solutions to the violations proposed by the company for efficacy. One of the vice presidents of the company suggested that the complaints lodged by the FDA were procedural only and had nothing to do with the quality of the products the company makes.