FDA EIR - IDT Biologika GmbH - November 22, 2016

An FDA surveillance inspection of IDT Biologika Gmbh, a sterile drug product manufacturer in Dessau-Rosslau, Germany, was conducted from November 14 to November 22, 2016. The inspection aimed to evaluate compliance with Current Good Manufacturing Practices (CGMP) as outlined in 21 CFR Part 210 & 211. The scope included the company's quality, material, facilities, equipment, packaging and labeling, and laboratory control systems.

The inspection resulted in twelve significant observations documented in an FDA-483 form, issued to the CEO. Primary issues included inadequate investigation of recurring consumer complaints (e.g., missing labels, vials, pens) and numerous deviations related to product defects (e.g., product outside stopper, fibers) without identifying root causes. The company failed to perform vendor qualification for contract laboratories and lacked adequate quality unit oversight for GMP documentation and analyst training. Laboratory system deficiencies encompassed incomplete records, such as uninvestigated unknown peaks in stability data and deleted non-conforming test results, uninvestigated system suitability failures, and method validation shortcomings like the absence of forced degradation studies. Additionally, there were failures to protect light-sensitive products during packaging, fully test drug products before release, and investigate facility differential pressure alarms. The company's management committed to providing a written response within fifteen business days, addressing the observations and outlining corrective actions.