FDA EIR - Lyocontract GmbH - September 20, 2019

An FDA surveillance inspection of Lyocontract GmbH was conducted from September 16 to September 20, 2019, as part of the agency's foreign inspection work plan, adhering to CPG 7356.002 for Drug Manufacturing Inspections. The inspection encompassed the firm's Quality, Materials, Production, and Laboratory systems. Lyocontract GmbH primarily contract manufactures parenteral drug products and was inspected concerning a specific drug product approved for administration in the United States. At the conclusion of the inspection, the FDA issued a Form 483, detailing three observations to Dr. Katrin Pesic, CEO. The main issues identified were that the accuracy, sensitivity, specificity, and reproducibility of test methods had not been properly established and documented. Furthermore, established test procedures and laboratory control mechanisms were not documented contemporaneously with their performance, and laboratory records lacked complete documentation for the testing and standardization of laboratory reference standards. These findings resulted in a "Voluntary Action Indicated" (VAI) classification, signifying that while observations were made, no immediate regulatory action beyond the firm's commitment is required. Dr. Pesic pledged to implement corrective actions for these observations and committed to submitting a written response to the FDA within 15 business days. The agency's recommendation is to re-inspect the facility as part of a routine work plan.