Medsource, Inc. – FDA EIR, Mar 31, 2015

Medsource, Inc. underwent an FDA inspection from March 26-31, 2015, scrutinizing its medical device and human tissue (HCT/P) distribution operations. The inspection, conducted under 21 CFR Part 1271 for HCT/Ps and 21 CFR Part 820 for medical devices, identified significant deficiencies. For HCT/Ps, violations included the lack of donor-eligibility summaries accompanying tissues, inadequate maintenance and documentation of storage temperatures with missing records and an uncalibrated device, undocumented review and release for distribution, and insufficient receiving inspections for damage or contamination.

Regarding medical devices, the company lacked established procedures for product storage, leading to issues like a gasoline container stored alongside instruments. There were no procedures or documentation for receiving, inspecting, and replenishing returned surgical instrument trays. Crucially, Medsource had not established Corrective and Preventive Action (CAPA) procedures, an adequate quality system, management review procedures, a quality plan, a quality policy, or conducted internal quality audits.

Medsource's President committed to correcting the four HCT/P-related observations within two weeks, promising a written response. The medical device observations were noted as