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OST Medical Inc. has received a letter from the U.S. Food and Drug Administration warning the company that some of its marketed products should have been approved by the agency as medical devices.
Founded in 1999, the Warwick, R.I.-based company sells feeding pumps, under the brand name Sentinel, that the FDA says are regulated devices, and for which the company has never sought approval. The FDA alleges that the company’s manufacturing plant does not conform to the agency’s standards for facilities that make regulated medical devices.
The FDA letter said that it found “ongoing systemic violations in the quality management system employed to ensure the safety and effectiveness of the medical devices.”
The FDA is requesting that the company respond in 15 days with a plan to correct the violations. The FDA warned that the agency has the authority to seize products, or enforce civil penalties, if OST Medical does not comply with the request.
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