FDA EIR - Nitro Quimica Corporation dba Alchemix A Nitro Quimica Corporation - February 14, 2019

Alchemix Corporation underwent a routine cGMP surveillance inspection by the FDA from February 8-14, 2019. This inspection, conducted under FDA Compliance Policy Manual 7356.002, identified significant deficiencies in the company's adherence to pharmaceutical manufacturing regulations (21 CFR Part 211). The inspection revealed six primary observations. Buildings were not maintained in clean and sanitary conditions, evidenced by standing water and bird-like feces in storage areas, coupled with unsealed openings facilitating pest ingress. Furthermore, the facility showed a lack of proper repair, including a 2x3 inch hole in a warehouse wall. Essential pharmaceutical equipment, specifically a pump, was found uncleaned, uncovered, and inappropriately stored in the manufacturing area, raising contamination concerns. Laboratory controls were also cited for lacking scientifically sound standards, including the use of an expired reagent for cleaning verification, an incomplete stability chamber validation protocol, and instances of laboratory results being approved before testing completion. The company also lacked crucial written procedures for handling non-conformances and for equipment usage and cleaning logs. Finally, batch records were found incomplete, missing dates for significant processing and packaging steps. Management, including General Manager Fernando Matheus, was issued a Form FDA 483 detailing these observations. Alchemix Corporation committed to responding in writing within 15 business days and implementing corrective actions to address the identified regulatory violations.