FDA 483 - WHPM Inc. - February 28, 2022

W.H.P.M., Inc. in Irwindale, CA, a medical device manufacturer, was cited with four observations on a Form 483 following an FDA inspection. The firm demonstrated significant deficiencies in establishing product identification procedures for export-only SARS-CoV-2 Antigen Test Kits, maintaining adequate complaint files, documenting acceptance of incoming products, and properly maintaining quality system records, specifically employee training records. These issues collectively indicate a lack of adherence to quality system requirements and proper documentation practices.