FDA Warns Cosco International Over Missing Process and Cleaning Validations

The FDA has issued a Warning Letter to Cosco International, Inc. after discovering that the contract manufacturer lacked both process and cleaning validations—a fundamental requirement in pharmaceutical manufacturing. The company also failed to respond to the prior Form 483.

Process validation ensures a ‘state of control’ across a product’s life cycle. The FDA expects companies to provide a detailed validation program, process performance qualification (PPQ) plans, monitoring activities, and assessments of equipment, raw materials, and manufacturing steps to identify and control variability.

Cleaning validation addresses cross-contamination risks, particularly for equipment used to manufacture multiple products, including cosmetics. The FDA emphasizes worst-case scenarios, such as highly toxic drugs, high active ingredient concentrations, low solubility in cleaning agents, difficult-to-clean products, and critical swab points. Companies must document updated work instructions, change management steps, and verification processes.

The FDA’s requirements essentially cover the full spectrum of process and cleaning validation. Full details of deficiencies are available in the Warning Letter on the FDA website.

01-10-2025