483
Oxford Performance Materials, Inc.FDA 483 - Oxford Performance Materials, Inc. - August 02, 2024
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An FDA inspection of Oxford Performance Materials, Inc. in South Windsor, CT, from July 30 to August 2, 2024, identified a significant regulatory compliance issue. The firm failed to submit multiple Medical Device Reports (MDRs) within the required 30-day timeframe. This indicates a lapse in their reporting procedures for device malfunctions that could cause or contribute to a death or serious injury.
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