483
Oakdale Precision IncFDA 483 - Oakdale Precision Inc - December 06, 2018
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Oakdale Precision Inc, a contract manufacturer in Oakdale, MN, was cited with two observations during an FDA inspection. The firm failed to establish design control procedures for a wheeled stretcher and lacked written procedures for handling Medical Device Reporting (MDR) events. These issues indicate significant deficiencies in their quality system.
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