FDA 483 - Boyd Technologies (Thailand) Co., Ltd. - June 28, 2023

An FDA inspection of Boyd Technologies (Thailand) Co., Ltd., conducted from June 26-28, 2023, revealed several deviations from quality system requirements. The inspection identified two primary concerns. Firstly, the company lacked adequate procedures to ensure purchased products and services conformed to specified requirements. Specifically, there was no evidence to demonstrate that the thermoforming process utilized by their contract manufacturer for certain critical components had been validated, indicating a gap in supplier control oversight.

Secondly, the firm did not adequately establish and implement procedures for managing changes to specifications. An initiated manufacturing change (ECN 2023008) lacked necessary verification and/or validation activities to assess its potential impact on materials. Additionally, the warehouse’s relative humidity was found to be uncontrolled, failing to meet the specific storage requirements for certain raw material adhesive parts, despite an internal monitoring procedure being in place. Boyd Technologies (Thailand) Co., Ltd. is expected to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with good manufacturing practices and rectify the identified systemic issues in their supplier management and change control processes.