483
Alpha ProTech Inc.Alpha ProTech Inc. – FDA 483, Jul 22, 2021
Record Details
An FDA inspection of Alpha ProTech Incorporated, a medical device manufacturer in Salt Lake City, UT, revealed two significant observations. The firm failed to adequately establish procedures for corrective and preventive actions, specifically regarding the verification of CAPA effectiveness. Additionally, complaint files were not adequately maintained, with evaluations for reportability lacking proper documentation.
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ID · 2832bdd8-c501-4f85-895a-c458f7d71faa
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