The Food and Drug Administration conducted an investigation of a OsteoSymbionics plant located in Cleveland, Ohio to learn that the company was manufacturing cranial implants which was not in accordance with Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation found in Title 21, Code of Federal Regulations (C.F.R.), Part 820.
The Food and Drug Administration determined that these cranial implants are devices which fall under the Federal Food, Drug and Cosmetic Act because the product is intended for the use of disease diagnosis, mitigation, treatment, disease prevention or may affect the structure or function of the body.
Furthermore, the Food and Drug Administration found that the company had inadequate design controls for the development of the cranial implants, did not establish or maintain procedures for ensuring that specific design requirements are met consistently, and did not establish procedures for validation which limited follow up inspections and testing; including an inadequate sterilization process. The company also failed to maintain a device master record for the cranial plate implants and did not adhere to other regulations.
In the warning letter from the Food and Drug Administration, authorities directed OsteoSymbionics to take immediate action to correct the violations. OsteoSymbionics has fifteen days to tell the Food and Drug Administration what the company has done to correct the violations and what they are doing to avoid violations in the future. The FDA warned that if OsteoSymbionics did not correct the violations, the company may be subject to regulatory action, such as, seizure, injunction, and/or civil monetary penalties.
In the U.S., most anyone can create a medical device and attempt to sell it. Many times, the most appropriate way for new medical companies to sell products to physicians is to participate in medical organization meetings that offer product displays for manufacturers. Medical organizations screen companies interested in exhibiting at medical organization meetings. Medical organizations have the right to refuse any company that the medical organization does not wish to allow participation in their meetings. Physicians also screen products before they make purchases for use in their practices.
Burton Padove, Indiana and Illinois lawyer, is available to help those who are injured because of defective products. He can be reached at (877) 446 5294.