Hologic Surgical Products Costa Rica, S.R.L. – FDA 483, Sep 12, 2024

During an inspection conducted from September 9 to December 2, 2024, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Hologic Surgical Products Co. (Hologic Costa Rica SRL), a medical device manufacturer. The inspection revealed two significant observations concerning the firm's quality system.

Firstly, the Device History Record (DHR) for the Biozorb Marker product did not consistently document manufacturing processes, specifically lacking recorded times for critical steps. This indicated a failure to demonstrate that the device was manufactured in accordance with the Device Master Record, posing a potential gap in product quality assurance.

Secondly, the company's procedures for managing product complaints were found to be inadequate. The FDA noted that procedures for trending and reviewing complaints were insufficient, and complete information was not always captured for reported issues. An example highlighted was an increase in complaint rates for the Biozorb product following a facility transfer, with no indication of a Corrective and Preventive Action (CAPA) being initiated to investigate the root cause.

These observations signify areas where Hologic Surgical Products Co. needs to enhance its quality system to ensure compliance with medical device regulations. The firm is required to conduct internal audits and implement corrective actions to address these deficiencies and prevent recurrence.