FDA 483 - Ethical Nutritional, LLC dba Remedy Makers - December 05, 2024

An FDA inspection of Ethical Nutritional, LLC, operating as Remedy Makers, conducted from December 3-5, 2024, identified significant deficiencies in their manufacturing processes and quality systems. The firm, a manufacturer of homeopathic drug products, received a Form FDA 483 citing seven observations indicative of non-compliance with current Good Manufacturing Practices (GMP).

Key issues included a widespread failure to establish written procedures for critical operations. Specifically, process validation was lacking for medicating bulk pellet production and the water purification system. Cleaning validation for non-dedicated equipment and procedures for supplier qualification and product recalls were also absent. The inspection further noted an inadequate number of qualified personnel, leading to delayed batch record completion and insufficient quality control review. Critical manufacturing equipment lacked proper qualification documentation.

The quality control unit demonstrated a lack of oversight, with no established change control program. Furthermore, the company failed to implement a written stability testing program for its drug products, some of which have been on the market for an extended period without stability data. Investigations into material failures were not documented, and procedures for comprehensive annual product reviews were either absent or inadequate.

To resolve these findings, Remedy Makers must implement robust corrective and preventive actions to ensure all manufacturing operations comply with regulatory requirements, thereby safeguarding product identity, strength, quality, and purity.