FDA WARNING_LETTER - TreyMed, Inc. - October 21, 2014

This FDA Warning Letter, dated February 10, 2015, was issued to TreyMed, Inc. following an inspection from October 7-21, 2014, in Sussex, Wisconsin. The inspection found that TreyMed, a contract manufacturer of Class II medical devices (b)(4) Sensor and (b)(4) Sensor, was not in conformity with current Good Manufacturing Practice (cGMP) requirements of the Quality System regulation (21 CFR Part 820), rendering their devices adulterated under section 501(h) of the Act.

Key violations include: 1. **Failure to control nonconforming product (21 CFR 820.90(a)):** TreyMed failed to follow its "Nonconforming Material SOP." Five out of five reviewed "Nonconforming Material Reports" (NMRs) lacked investigation determinations and disposition authority. Rework for nonconforming materials was undocumented, and initial test failures for incoming materials were not documented via NMRs, with nonconforming adapters released for production without rationale. 2. **Inadequate Device History Record (DHR) (21 CFR 820.184):** DHRs did not demonstrate manufacturing in accordance with the Device Master Record (DMR). "Line Setup/Clearance" forms were missing, incorrect Bill of Materials (BOM) revisions were used, and unapproved work/