The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their endoscope and reprocessor manufacturing facilities.
The warning letters allege medical device reporting (MDR) and quality system violations at the manufacturing operations.
An Olympus representative told MassDevice sister site Medical Design & Outsourcing that the medtech manufacturer would issue a public response as soon as today.
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