FDA Reveals More Violations by Medical Device Maker Linked to Deadly Infections
(HealthDay News) — New violations by the maker of medical scopes recently linked to deadly infections in patients have been discovered by the U.S. Food and Drug Administration.
Olympus Corp. did not alert officials about a cluster of 16 infections in patients who underwent procedures with the company's scopes in 2012, the FDA said in a warning letter posted online Monday, the Associated Press reported. The infections were disclosed by Olympus only in 2015, when the company was already being investigated for more recent outbreaks.
Regulations require medical device makers to report serious problems to the FDA within 30 days of learning about them, the AP reported. The warning letter also noted that Olympus has no standard procedure for immediately reporting serious problems with its medical devices, even though that is an FDA requirement.
"We are reviewing the FDA's warning letter so that we can provide the required response in a timely manner," an Olympus spokesman told the AP.