FDA EIR - Grifols Therapeutics LLC - April 01, 2014

An FDA inspection of Grifols Therapeutics Inc., a key manufacturer of licensed commercial plasma-derived drug products, was conducted at its Clayton, NC facility from March 18 to April 1, 2014. This comprehensive review was performed under the regulatory framework of CP 7345.848, specifically "Inspection of Biological Drug Products (CBER)," as part of the Team Biologics FY' 2014 work plan. The inspection, designated as a Level II assessment, primarily focused on the firm's critical Quality and Production Systems, while also examining aspects of their Facilities and Equipment, Materials, and Laboratory Control Systems. Grifols Therapeutics operates under US License 1871, producing a wide range of essential biological products such as Koate DVI, Gamunex-C, and various Plasbumin formulations. Although the inspection report outlines sections for "Objectionable Conditions and Management's Response" and "Voluntary Corrections," the specific details of any identified main violations or the corresponding required actions are not accessible in this provided document due to significant redaction. The report does indicate that there had been one product recall by the company since the last Team Biologics inspection. The FDA's oversight ensures compliance with manufacturing standards for these vital biological drug products.