FDA 483 - Nitro Quimica Corporation dba Alchemix A Nitro Quimica Corporation - February 21, 2025

Nitro Corporation, an OTC drug manufacturer in College Park, GA, was inspected by the FDA, revealing significant deficiencies across multiple areas. The inspection found issues with quality control, unwritten reprocessing procedures, inadequate storage conditions, and failures in equipment cleaning and qualification. These observations indicate a lack of adherence to good manufacturing practices, leading to product quality problems and customer complaints.