FDA 483 - Coretex Products Inc. - April 28, 2021

An FDA inspection of Coretex Products Inc. in Bakersfield, CA, a packer/repacker of drug products, revealed significant deficiencies in production, labeling, and equipment cleaning controls. The firm failed to validate critical processes and cleaning procedures, leading to issues like underweight products and incorrect label usage. These observations indicate a lack of adequate controls to ensure drug product quality, identity, and purity.