FDA 483 - PRENOSIS INC - November 19, 2025

This FDA Form 483 document details observations from an inspection conducted between November 17-19, 2025, issued to Bobby Reddy Jr., CEO, of an unnamed firm. The inspection revealed significant deficiencies in the company's quality management system, pointing to a lack of established and maintained procedures essential for regulatory compliance.

Key issues include the absence of written Medical Device Reporting (MDR) procedures, despite internal documents referencing them for compliance with 21 CFR 820.198. Employees confirmed that specific adverse event procedures (SOP-14 and SOP-63) were never developed. Additionally, the firm lacked adequate procedures for controlling non-conforming products, with a referenced SOP-10 (for 21 CFR 820.90 compliance) also found to be non-existent. Furthermore, the quality plan itself was deemed inadequate, as the Quality Manual contained outdated references to procedures, failing to reflect current document revisions.

These observations indicate a need for the company to establish and maintain robust quality system processes. The firm has committed to addressing and correcting all identified observations by December 31, 2025.