FDA 483 - Thai Hospital Products Co., Ltd. - June 22, 2023

An FDA inspection of Thai Hospital Products Co., Ltd., located in Pakkret, Nonthaburi, Thailand, was conducted from June 19-22, 2023. The inspection resulted in the issuance of an FDA Form 483, detailing two significant observations concerning the firm's quality system, which are crucial for compliance with federal regulations for medical device manufacturers.

The first observation highlighted inadequate establishment and implementation of corrective and preventive action (CAPA) procedures. Specifically, the company failed to effectively document, investigate, and verify the effectiveness of actions taken when production key performance indicators exceeded target limits. A recurring issue involved manufacturing machines where a lack of preventive maintenance was identified as a root cause for persistent problems, despite records indicating maintenance was performed, signifying ineffective corrective measures.

The second critical finding was the absence of written procedures for Medical Device Reporting (MDR). Thai Hospital Products Co., Ltd. had not developed a formal process for identifying, evaluating, communicating, and timely transmitting events that are subject to MDR requirements, which is a fundamental regulatory expectation for medical device manufacturers.

In response to the FDA Form 483, Thai Hospital Products Co., Ltd. committed to correcting both observations. The company is now required to implement appropriate actions to resolve these deficiencies, ensuring full compliance with regulatory standards for product quality and safety.