FDA 483 - IBT Scientific Llc - December 19, 2019

Integrated Biomedical Technology, Inc. in Elkhart, IN, was inspected from December 17-19, 2019, and received a Form FDA-483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate corrective and preventive action procedures, poorly maintained device history records, and failures in equipment calibration and internal quality audits. These issues indicate systemic problems, with several deficiencies recurring from a previous FDA audit.