FDA 483 - Medinatura New Mexico, inc. - May 23, 2025

Medinatura New Mexico, inc., a drug product manufacturer in Albuquerque, NM, received an FDA Form 483 citing significant deficiencies. The firm failed to adequately validate manufacturing processes for new products, ensure comprehensive testing of incoming raw materials, and establish and follow proper cleaning and maintenance procedures for equipment. These issues indicate a lack of robust quality control and potential risks to product quality and safety.