By Brad Perriello
A former accountant for SpineFrontier sued the company this month for wrongful termination, alleging that the spinal implant maker fired her for raising concerns about manufacturing processes later flagged by the FDA in a warning letter.
Patricia Katz was hired by Beverly, Mass.-based SpineFrontier as a senior accountant in February 2011, according to court documents. But soon after her employment began, “Katz voiced concern about SpineFrontier’s lot tracking and tracing procedures, which involved little to no tracking,” she alleged in a lawsuit filed in the U.S. District Court for Massachusetts.
After her immediate supervisor dismissed her concerns, and with a pair of compliance classes under her belt, Katz allegedly “learned that SpineFrontier’s lot tracking and tracing procedures violated federal safety regulations for medical devices” and subsequently opened a Corrective & Preventive Action report documenting the deficiencies.
“But when Katz opened a CAPA for SpineFrontier’s lot recording deficiencies, the company’s chief innovation officer promptly closed it,” the lawsuit alleged.