FDA 483 - ESTABLISHMENT LABS SA - July 26, 2024

During an FDA inspection conducted from July 23-26, 2024, Establishment Labs SA received a Form FDA-483 detailing three significant observations concerning its quality system requirements for medical devices. The inspection was carried out pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act.

The primary violation involved the late submission of Medical Device Reports (MDRs). Specifically, 19 MDRs for the Motiva Flora Tissue Expander were not reported within the mandated 30-day timeframe after the company received information suggesting potential serious injury or death. These complaints dated from November 2023 through April 2024.

Further observations included inadequate documentation for a validated process, where training was not demonstrated for an individual executing a critical test during the Operation Qualification for the Motiva Assembly. Lastly, the company's internal audit program had a conflict of interest, as individuals conducting quality audits held direct responsibility for the matters being audited.

Establishment Labs SA acknowledged these findings and indicated a commitment to correct each observation. The company is now responsible for implementing comprehensive corrective actions to address these deficiencies and ensure full adherence to regulatory standards for medical device manufacturing and reporting.