FDA EIR - Charter Medical LLC - September 26, 2014

An FDA establishment inspection was conducted at Charter Medical Limited in Winston Salem, NC, from September 22 to September 26, 2014. The inspection, a Level II (Baseline) QSIT review under Compliance Program 73825.845, focused on the firm's operations as a Class II medical device manufacturer, producing items such as blood administration sets, blood bags, and cryogenic storage bags.The inspection covered Management Controls, Production and Process Controls, Corrective and Preventive Action procedures, and Design Controls subsystems. Notably, no significant observations or violations were found during this inspection, and consequently, no Form FDA-483 (Inspectional Observations) was issued to the firm's management. This indicates a compliant operational status.The report also noted that a previous inspection in 2012 had identified deficiencies related to incomplete process validation activities and an inadequate sampling plan. However, during the current inspection, Charter Medical Limited's quality system corrections addressing these prior issues were deemed adequate. Therefore, no new regulatory actions were required as a result of this inspection, reflecting satisfactory adherence to medical device manufacturing regulations.