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483
•Alpha ProTech Inc.•July 22, 2021

FDA 483 - Alpha ProTech Inc. - July 22, 2021

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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.

Company
Alpha ProTech Inc.
Inspection Date
July 22, 2021
Product Type
Device
Office
Denver District Office
Person
  • Matthew M. Vernon (investigator)
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ID · 2832bdd8-c501-4f85-895a-c458f7d71faa

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