FDA 483 - ESTABLISHMENT LABS SA - July 26, 2024

During an inspection conducted from July 23 to July 26, 2024, the U.S. Food and Drug Administration (FDA) issued a Form FDA-483 to ESTABLISHMENT LABS SA, a medical device manufacturer located in Alajuela, Costa Rica. The inspection revealed three significant observations pertaining to the company's quality system and regulatory compliance. Firstly, ESTABLISHMENT LABS SA failed to submit Medical Device Reports (MDRs) within the required 30-day timeframe for the Motiva Flora Tissue Expander, with 17 out of 19 MDRs reported late from complaints received between November 2023 and April 2024. Secondly, the inspection identified inadequate documentation regarding individuals performing validated processes; specifically, an Operation Qualification for a critical assembly step of the Motiva device lacked documented training for one individual who executed a key validation test. Finally, the FDA observed that individuals conducting quality audits were not independent of the matters being audited, contradicting the company's own internal audit procedure. These observations indicate potential deviations from current good manufacturing practices and regulatory requirements concerning quality systems and adverse event reporting. ESTABLISHMENT LABS SA has indicated a promise to correct all identified issues to ensure compliance with FDA regulations.