The Associated Press is reporting that the FDA has warned Johnson & Johnson that it could face fines and other sanctions for selling faulty insulin pumps and delaying disclosures of serious injuries to diabetics who used them.
The FDA ordered J&J’s Animas Corp. unit to promptly provide a plan to rectify its failure to report within 30 days cases where its device may have caused or contributed to death or serious injury.
In a warning letter sent to Animas on Dec. 27 and posted online by FDA Tuesday, the agency wrote that inspectors found Animas, which is based in West Chester, Pa., never reported on one case of serious patient injury and delayed reporting on two others. Those patients were hospitalized with dangerously high blood sugar, respiratory failure and coma, and a life-threatening complication called diabetic ketoacidosis that’s caused by lack of insulin to break down blood sugar.
The letter states that the initial response from Animas to the problems detailed in the inspection report was not adequate. It gives the company, part of New Brunswick, N.J.-based J&J, 15 business days to respond.
The Code of Federal Regulations (CFR) sets out strict reporting requirements in Section 803 for medical device companies. This report is known as a Medical Device Report or MDR. The regulations include short windows to report deaths, serious injuries, and other product problems. The J&J case makes clear that the FDA will strictly enforce these regulations. Medical device manufacturers, initial importers and others should contact legal counsel to determine whether a MDR is required and to ensure it is timely filed.
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