FDA WARNING_LETTER - Mid-Link Testing Company, Ltd - March 06, 2024

The FDA issued a Warning Letter to Mid-Link Testing Company, Ltd following an inspection from February 26 to March 6, 2024, by the Office of Bioresearch Monitoring Operations (OBIMO). The inspection assessed compliance with Good Laboratory Practice (GLP) regulations (21 CFR Part 58) for nonclinical studies, including acute systemic toxicity and rabbit pyrogen tests, used in device development. The FDA identified serious violations impacting data validity and integrity. Key deficiencies included the study director's failure to ensure accurate data recording and verification, leading to fabricated animal weights and missing clinical observations. The firm also failed to conduct studies according to protocols, exemplified by inadequate temperature probe calibration for pyrogen tests and unsecured test articles. Inadequate Standard Operating Procedures (SOPs) and the study director's failure to authorize or document deviations were noted, affecting animal identification and protocol elements. Testing facility management failed to ensure personnel clearly understood their functions, with incomplete training for scoring erythema and edema. Furthermore, the Quality Assurance Unit (QAU) failed to fulfill its responsibilities, including maintaining a complete Master Schedule, identifying deviations, and reviewing final reports for accuracy. Finally, animal identification on housing units was inadequate. These systemic data integrity issues, occurring across multiple studies and months, raise significant concerns about the quality and integrity of safety data submitted to the FDA, potentially jeopardizing public health. Mid-Link must provide documentation of comprehensive corrective and preventative actions, including timelines and effectiveness monitoring, within 15 working days. Failure to adequately respond could result in further regulatory action, including disqualification.