FDA 483 - MACSEN DRUGS - September 01, 2023

During an FDA inspection from August 21 to September 1, 2023, Nutraceutical Corporation, a dietary supplement manufacturer in Park City, UT, received a Form FDA 483 listing significant observations related to its manufacturing and quality control processes. The inspection highlighted several departures from current Good Manufacturing Practices for dietary supplements. A primary concern was the company's failure to establish adequate specifications for components, including not verifying the identity of raw materials like Cellulose and Fenugreek Seed Powder through scientifically valid methods. This was a repeat observation regarding component identity from previous inspections. Furthermore, Quality Control operations were found deficient, as personnel did not ensure identity and strength testing for dietary ingredients or finished products, and in some cases, released products (e.g., Solaray Vitamin D-3, Solaray Zinc) that failed internal specifications. The company's Master Manufacturing Records were incomplete, lacking essential information on in-process and finished batch testing, as well as corrective action plans for when specifications were not met. Lastly, Nutraceutical Corporation lacked proper written procedures for holding finished dietary supplements, specifically regarding environmental conditions like temperature and humidity, despite observing high temperatures in the warehouse. These observations indicate a need for comprehensive corrective actions to ensure compliance with federal regulations for dietary supplement manufacturing.