CMP Pharma Inc – FDA EIR, May 25, 2017

An FDA inspection of CMP Pharma Inc. (CMPPI) was conducted on May 25, 2017, specifically targeting the company's quality system for Class I enema kits. This inspection marked CMPPI's first under the regulatory framework of CP 7382.845, "Inspection of Medical Device Manufacturers," covering Management Controls, CAPA, and Purchasing & Production Controls subsystems. Notably, no FDA-483, Inspectional Observations, were issued, indicating the absence of formal violations. However, the inspection did identify two areas for improvement during the close-out discussion. Management acknowledged the need to establish specific training procedures for employees tailored to medical device manufacturing regulations, as current training was based on drug manufacturing Good Manufacturing Practices (GMPs). Additionally, there was a recognized lack of management awareness regarding Unique Device Identifier (UDI) compliance for the enema kits. As a required action, the Director of Quality Assurance committed to contacting the enema kit manufacturer to clarify UDI compliance. Management promised to implement the discussed corrections.