Biomedical Systems Corp – FDA EIR, Nov 17, 2016

An FDA inspection of Biomedical Systems Corp, a contract research organization in Maryland Heights, MO, occurred from November 8 to November 17, 2016. Conducted under CP7348.810 to assess a specific clinical trial protocol, the inspection identified critical compliance issues. A one-item FDA Form 483 with four observations was issued, citing failures to conduct the study in accordance with the investigational plan, referencing regulatory principles such as 21CFR312.50.

Key violations included: a) the use of unvalidated third-party software (Mint Lesion) that inaccurately measured lesions, requiring re-reads for 126 subjects; b) insufficient variability testing for image readers, deviating from standard operating procedures and the study charter; c) inadequate audit trails for 1055 data changes, with unidentifiable reasons due to software limitations and lack of clear procedures; and d) significant delays in Quality Assurance assessments, with 774 out of 2663 time points reviewed beyond the required two-day timeframe. Further concerns included incomplete document provision and undocumented software training for some personnel.

Management was warned of their responsibility to comply with the Food, Drug, and Cosmetic Act, with potential regulatory action for non-compliance. A response to the observations within 15 business days was requested.