FDA 483 - WHPM Inc. - January 30, 2024

WHPM Inc. in Irwindale, CA, a manufacturer of diagnostic test kits, was cited for multiple significant quality system deficiencies during an FDA inspection. Observations included inadequate control of nonconforming products, failure to maintain device history records, and lack of proper procedures for product disposition and supplier management. Additionally, the firm failed to calibrate critical production equipment according to schedule.