FDA EIR - Packaging Coordinators, LLC - December 18, 2020

An FDA inspection of Packaging Coordinators, LLC, located in Philadelphia, PA, was conducted from December 15-18, 2020. This high-priority, mission-critical inspection focused on the company's role as a human drug product contract labeler and secondary packager, specifically concerning biological drug products, under regulatory framework C.P. 7345.848. The inspection encompassed operations from receiving unlabeled vials to final shipment of packaged products, including the security and storage of labels and packaging materials. Investigators also reviewed the firm's ongoing efforts to qualify a newly installed vial packaging line, comprising a labeler and cartoner, for future use with biological products. A wide range of documents, including Standard Operating Procedures, equipment qualifications, material controls, and quality agreements, were examined. Significantly, at the conclusion of the four-day inspection, no Form FDA 483, Inspectional Observations, was issued. This indicates that no significant violations or issues were identified, and consequently, no immediate regulatory actions were required from this inspection. The company is proceeding with the final stages of equipment qualification and process validation for its new packaging line.