FDA EIR - SGS Analytics Germany GmbH - October 30, 2019

An FDA pre-approval inspection of SYNLAB Analytics & Services Germany GmbH, a contract testing laboratory in Aachen, Germany, was conducted from October 28 to October 30, 2019. The inspection, performed under regulatory guidance for pre-approval and sterile drug process inspections (CPGM 7346.832 and 7356.002A), focused on the firm's related substance HPLC-MS testing. The inspection revealed two primary deficiencies documented on Form FDA-483, referencing 21 CFR 211.68(b) and 21 CFR 211.22(d) related to Current Good Manufacturing Practice (cGMP). Firstly, appropriate controls were not exercised over computer systems, as non-validated, pre-filled data sheets lacked adequate security measures like password protection, alteration prevention, and audit trails, and were not reviewed by the quality unit for accuracy. Secondly, the quality control unit failed to follow its own procedures by not initiating a change control for the installation and qualification of laboratory equipment described in a validated analytical method transfer. The Site Manager, Dr. Ralph Nussbaum, acknowledged these observations and committed to submitting a written response outlining corrective actions to the FDA within 15 business days.