FDA Warns Orthopedic Implant Manufacturer Over Quality System Violations
Posted 21 May 2019 | By
The US Food and Drug Administration (FDA) issued a warning letter to Orchid Orthopedic Solutions over violations linked to the agency’s quality system regulation, including inadequate complaint handling procedures.
The warning letter cites a total of six violations. These became significant violations after the manufacturer of orthopedic implants failed to ease the agency’s concerns initially noted in a Form 483, following a 12-day inspection in February at the company’s site in Farmington Hills, MI.
Orchid failed to require documentation in certain nonconforming product reports at the time of the inspection. The firm’s device cleaning processes as well as its procedures for implementing corrective and preventive action and conducting quality audits were deemed inadequate.
The inspection also flagged the firm’s complaint handling procedure for failing to address complaints in a timely manner. The warning letter points to lack of investigations into two 2018 complaints due to “contamination in coating” and “tensile Test failure,” more than 150 days after the complaint was received. A third complaint related to “non-uniform coating” was marked as investigation completed in October 2018, 158 days after it was received.
FDA’s evaluation of the firm’s March letter determined that its response to four of the violations cannot be assessed, while responses to the other two violations are inadequate. The firm, however, submitted a second response letter to FDA last month, which was not addressed in the warning letter. FDA said it still needs to verify its complaint handling procedures and implant cleaning processes during a re-inspection.
Bill Ditty, Orchid Orthopedic Solutions’ vice president of quality assurance, compliance and legal, told Focus
that the firm “is deploying internal and external resources to address the corrections related to the warning letter with immediacy.” Ditty added that Orchid’s Farmington Hills facility “is the only facility impacted” by the warning letter, which “is not product-related and the findings are procedural.”