FDA EIR - Cintas Corporation - June 24, 2016

An FDA inspection of Cintas Corporation's Mason, OH facility was conducted from June 20-24, 2016. The inspection, a Level 1 QSIT under Compliance Program 7382.845, focused on the company's operations as a manufacturer of Class 1 first aid kits and a repacker of Class 1 medical devices and non-prescription drugs. The inspection revealed seven significant deficiencies, documented on an FDA Form 483. Key violations included the lack of established procedures for corrective and preventive actions (CAPA), inadequate document control, and the absence of written procedures for Medical Device Reporting (MDR). Additionally, Cintas failed to adequately maintain device master records and lacked established procedures for device history records, quality audits, and management review. Two discussion items were also noted: purchasing controls did not require suppliers to notify Cintas of product or service changes, and there were contradictory elements between the firm's corporate policies and its new Standard Operating Procedures. The company was also advised to update its FDA listing, as it distributes, but does not repackage, Automated External Defibrillators (AEDs). Cintas Corporation is required to address these observations by establishing and implementing the necessary quality system procedures and records. This includes developing robust CAPA, document control, MDR, device master and history records, quality audit, and management review processes. Furthermore, the company must align its purchasing agreements with regulatory expectations and harmonize its internal policies and procedures to ensure consistent compliance with the Food, Drug and Cosmetic Act.