FDA 483 - Hakko Co., Ltd. - May 25, 2023

During an FDA inspection conducted from May 22 to May 25, 2023, the medical device manufacturer Hakko Co., Ltd., located in Chikuma, Nagano, Japan, received a Form FDA 483 outlining significant observations related to its manufacturing quality systems. The inspection highlighted five key areas of concern indicating potential non-compliance with regulatory requirements for medical device production. Firstly, production processes were found to be inadequately developed, failing to ensure devices consistently conform to their specifications, specifically lacking established manufacturing procedures. Secondly, a critical bonding process for a medical device component had not been properly validated according to internal procedures, posing risks to product reliability. Thirdly, the firm lacked adequately established procedures for accepting in-process products. Further issues included deficiencies in device history records, which did not consistently demonstrate that devices were manufactured in accordance with their master records, as observed in a review of eleven records. Finally, the company's sampling plans for in-process testing were not based on valid statistical rationale, raising questions about the reliability of quality control checks. These observations underscore the necessity for Hakko Co., Ltd. to adhere to robust manufacturing quality requirements mandated for medical device companies. In response to the inspection, Hakko Co., Ltd. promised to correct each of the noted observations, signifying a commitment to implement necessary corrective actions to ensure full compliance with regulatory standards and safeguard product quality.