GlaxoSmithKline dba Human Genome Sciences Inc – FDA EIR, Jan 29, 2020

An FDA pre-license inspection of Human Genome Sciences, Inc. in Rockville, MD, took place from January 22-24 and 27-29, 2020. The inspection assessed the manufacturing of an intermediate drug substance, focusing on compliance with Good Manufacturing Practices (GMP) and relevant FDA guidelines for therapeutic drug products and active pharmaceutical ingredients. The inspection resulted in a 3-item FDA Form 483, detailing several objectionable conditions. Key findings included: manufacturing processes not conforming to established procedures, specifically regarding unauthorized repetition of process steps and impermissible re-printing of batch records following deviations. Additionally, the company failed to consistently follow its written procedures, evident in delays in initiating deviation records and operators performing tasks without completing required training. The third main observation cited inadequate adherence to training procedures, with employees not completing training before executing operations. Verbal observations also highlighted concerns such as critical testing and reagent manufacturing occurring at an unlisted facility, a lack of deviation reporting for a production delay causing batch termination, and inconsistent time reporting for sample collection. Human Genome Sciences, Inc. is required to address these inspectional observations. This involves implementing robust corrective and preventive actions to ensure full compliance with GMPs, adherence to all written procedures, and rectification of training program deficiencies, as well as addressing the facility listing and documentation inconsistencies.