FDA EIR - Surgical Technologies Inc - January 31, 2020

A routine, pre-announced FDA inspection of Surgical Technologies Inc (STI), a Class II and III contract medical device manufacturer located in Saint Paul, MN, was conducted from January 29 to January 31, 2020. The inspection was carried out under the regulatory framework of Compliance Program (CP) 7382.845A, a Quality System Level I baseline inspection, utilizing the Quality System Inspectional Technique (QSIT). The review focused on key quality systems, including management control, corrective and preventive action (CAPA), and production and process control (PAPC).

Notably, the inspection concluded without any objectionable observations or significant deviations being identified, and no FDA-483 Inspectional Observations were issued. This positive finding indicates STI's compliance with regulatory standards for medical device manufacturing during the inspection period. The inspection involved reviewing management control procedures, internal audit records, a sample of CAPA and complaint records, and observation of manufacturing processes for a Class I sterile device, including its sterilization validation and requalification. As no violations or issues were found, no specific actions were formally required by the FDA. However, STI management was advised to continue identifying and addressing any potential quality system deficiencies through their robust internal quality audit processes.