FDA 483 - WHPM Inc. - November 18, 2022

WHPM Inc. in Irwindale, CA, was inspected, revealing significant deficiencies in its quality system. The firm failed to adequately establish procedures for the control and distribution of finished devices designated for export, particularly regarding required recordkeeping. Additionally, the inspection found a lack of established records for acceptable contractors and an inadequate Medical Device Reporting (MDR) procedure concerning documentation and standardized event evaluation.