The FDA has issued a warning letter to Orchid Orthopedic Solutions, a major design and manufacturing outsourcer in the orthopedic medical device space, for alleged violations including unsanitary water used to clean implants.
The letter, dated May 13 and released today, says the company’s facility at 23149 Commerce St., Farmington Hills, Mich. failed to adequately sanitize its water system in September 2018 despite bioburden test results being “too numerous to count.” Orchid Orthopedic specializes in applying coatings to orthopedic implants that promote bone ingrowth, according to the agency.