483
NuPak Medical, LtdNuPak Medical, Ltd – FDA 483, Feb 25, 2022
Record Details
An FDA inspection of NuPak Medical in San Antonio, Texas, a device manufacturer, revealed two observations related to the firm's quality system. The company failed to implement its procedures for corrective and preventive actions (CAPA) and did not process customer complaints in a uniform and timely manner as required by its own established procedures. These issues indicate a breakdown in the firm's adherence to its internal quality management processes.
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ID · c2f91051-4c92-41fc-a80b-a35595ad412f
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