FDA 483 - Saol Therapeutics Inc - August 01, 2025

During an inspection conducted from July 29, 2025, to August 1, 2025, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Saol Therapeutics Inc., a medical device manufacturer located in Roswell, GA. The inspection identified a significant observation regarding the company's quality system and its compliance with regulatory requirements.

The main issue cited was that the design history file for Saol Therapeutics' GSTZ1 Haplotype Test device, intended to assist in targeted dosing for patients with Congenital Lactic Acidosis, did not adequately demonstrate that the device's design adhered to its approved design plan. Specifically, key analysis, evaluation, and risk management activities related to the device's regulatory submission were found incomplete. For example, the firm's "Requirements Development Planning Template" listed several critical project phases, including User Needs, Design Inputs, Implementation/Design Output, and Design Validation, as still "In Progress" or "Pending." Additionally, a required test report for a comparative analysis protocol, despite the protocol being marked as "Completed," had not been finalized or received by the firm.

This observation indicates a need for enhanced adherence to design control procedures, as mandated under the Federal Food, Drug and Cosmetic Act, which governs medical device manufacturing. Saol Therapeutics Inc. is responsible for performing comprehensive internal self-audits to identify and correct all quality system deficiencies. The firm acknowledged the observation and committed to implementing corrective actions.