483
APS Materials, Inc.APS Materials, Inc. – FDA 483, Jan 30, 2020
Record Details
APS Materials, Inc., a medical device manufacturer in Dayton, OH, was inspected by the FDA from January 28-30, 2020. The inspection revealed deficiencies in the firm's complaint handling system, specifically regarding the maintenance of complaint files and the completeness of complaint investigation records. These issues indicate a lack of adequate procedures for evaluating Medical Device Reporting requirements and documenting essential investigation details.
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ID · 50b3f4d3-1d34-4a30-9ea9-dc81fb3208c7
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