FDA EIR - Checkpoint Surgical Inc - March 15, 2018

An FDA inspection of Checkpoint Surgical Inc., a Cleveland, OH-based Class II medical device manufacturer, was conducted from March 1 to March 15, 2018. This initial inspection, focusing on Corrective and Preventive Action (CAPA) and Production and Process Controls (P&PC) subsystems, assessed compliance with medical device regulatory frameworks, particularly 21 CFR 820.

Four significant observations were issued on an FDA-483 form. The main issues included inadequately established procedures for: 1. Receiving, reviewing, and evaluating complaints, specifically lacking clear supplier notification for manufacturing issues and insufficient documentation of failure investigations (21 CFR 820.198(a)). 2. Acceptance activities, which did not clearly define requirements for reviewing and approving contract manufacturer documentation or temporary deviations (21 CFR 820.80(a)). 3. Corrective and preventive actions, noted by the premature closure of a CAPA related to a complaint trend without documented preventive actions or effectiveness (21 CFR 820.100(a)). 4. Process controls, particularly regarding the control and revision of the Process Risk Analysis (PFMEA), including its update mechanism and documentation of risk reduction methods (21 CFR 820.70(a)).

Management promised to correct all observations. Corrections for complaint and process control procedures are expected within 90 days. For acceptance activities and CAPA, the company reported corrections prior to the inspection's close, though these were not verified by the FDA investigator. The inspection highlighted systemic deficiencies in critical quality system elements for this sterile medical device manufacturer.