483
APDM Wearable Technologies, Inc.FDA 483 - APDM Wearable Technologies, Inc. - March 10, 2022
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An FDA inspection of APDM Wearable Technologies, Inc. in Portland, OR, identified one observation concerning the inadequate implementation of equipment maintenance procedures. The firm failed to properly document preventative maintenance activities for its equipment, as required by its internal procedures. This indicates a lapse in adherence to established quality system requirements.
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