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.
The FDA, which conducted the inspection from Feb. 4 to Feb. 15, 2019, also claims that Orchid Orthopedic failed to validate the manual cleaning process for certain implants, and that the company failed to document device reworks, defects or test failures.
The company also exhibited faulty quality control during two FDA inspections and failed to timely process complaints, the agency said.
Orchid Orthopedic’s responses to the alleged violations either did not adequately address the alleged violations or could not be assessed, the letter says. The Holt, Mich.-based company did not immediately respond to a request for comment. Orchid has more than 1,500 employees working at a dozen manufacturing sites in the U.S., U.K., Switzerland and China.