483
APN Health LLCFDA 483 - APN Health LLC - October 10, 2019
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APN Health LLC, a medical device manufacturer in Waukesha, WI, was cited with two observations on a Form FDA 483. The inspection revealed significant deficiencies in the firm's design verification procedures for its Navik 3D software and its complaint handling processes. These issues indicate a failure to adequately establish and follow internal quality system procedures.
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ID · d55e871b-9c9f-4463-bb09-d537aaf6f679