FDA 483 - WHPM Inc. - January 30, 2024

During an FDA inspection conducted from January 16 to January 30, 2024, at WHPM Inc. in Irwindale, California, several significant deficiencies were observed regarding the company's adherence to quality system regulations for medical device manufacturing. The inspection identified six primary issues.

Firstly, the firm failed to adequately control non-conforming products. Specifically, recalled SARS-CoV-2 Antigen Test kits were found in the warehouse without proper quarantine or labeling, indicating a breakdown in preventing unintended use. Secondly, the acceptance status of incoming products was not consistently identified, and records for acceptance activities for various SARS-CoV-2 Antigen Test Cassettes were incomplete or absent. Similarly, products in the production room lacked clear status identification.

Thirdly, crucial device history records for several finished device lots, including various COVID-19 tests, were not maintained, hindering the ability to verify production and distribution quantities. Fourthly, procedures for the review and disposition of non-conforming products, such as those designated for scrap, lacked appropriate Quality Assurance approval, and some scrapped product was found improperly handled. Fifthly, the company lacked established records and quality agreements with key suppliers, including one responsible for export-only products, and no written agreement with their freight forwarding agency. Finally, essential production equipment, including sealing and cutting machines used for COVID-19 test cassettes, was found to have overdue calibration, violating periodic inspection requirements.

WHPM Inc. is required to address these observations with comprehensive corrective actions to ensure compliance with regulatory standards for medical device manufacturing.