FDA 483 - Grifols Therapeutics LLC - October 21, 2016

During an FDA inspection from October 12-21, 2016, Grifols Therapeutics, Inc., a plasma fractionator, received an FDA Form 483 citing significant manufacturing deficiencies. The primary issues included a failure to identify the root cause of persistent leaking/dripping fill lines, resulting in ineffective maintenance and incomplete quality investigations. The company also failed to adequately investigate critical maintenance work orders, and the Quality Unit's review processes were found insufficient. Several written procedures (SOPs) for sanitization, container integrity defect investigations, tank evaluation for rouging, and equipment status labeling were deemed inadequate. Furthermore, components were released without full testing, and investigations into product particulates, such as those in HyperHEP, were untimely, with safety assessments delayed. Various facility and equipment issues were observed, including brown material and water droplets on surfaces, product residue, improper hose placement, and incorrect equipment status labeling in aseptic areas. These observations indicate potential non-compliance with the Federal Food, Drug, and Cosmetic Act and current Good Manufacturing Practices. Grifols Therapeutics, Inc. is expected to provide a comprehensive response detailing corrective and preventive actions to address these serious findings and ensure regulatory compliance.