FDA EIR - ThermoFisher Scientific - July 24, 2014

An FDA inspection of ThermoFisher Scientific's Basingstoke, United Kingdom facility was conducted from July 21-24, 2014, to evaluate adherence to medical device quality system regulations, including Medical Device Reporting and Correction and Removal requirements (Compliance Program 7382.845). Significantly, no FDA-483 was issued, indicating an absence of major regulatory violations during this inspection. The inspection did identify minor documentation issues within Batch Manufacturing Records, such as missing production management sign-offs, lack of balance printouts, and inconsistencies. ThermoFisher Scientific's management acknowledged these observations and demonstrated proactive efforts in updating forms and providing training to manufacturing and quality control staff. Furthermore, a review of the company's Corrective and Preventive Action (CAPA) system highlighted several confirmed customer complaints and associated Class 2 and Class 3 recalls. These issues included product quality concerns like "blank discs" or "no zones" in Antibiotic Susceptibility Test discs, and "incorrect cartridges." In response, the firm had already implemented process improvements, such as upgrading camera and dosing procedures, retraining production staff, and modifying manufacturing records to enhance oversight. The company showed ongoing commitment to addressing these recurring issues through active corrective measures.