FDA EIR - Packaging Coordinators, LLC - October 21, 2022

An FDA inspection of Packaging Coordinators, LLC, a contract labeler and packager of biological and pharmaceutical drug products in Philadelphia, PA, was conducted from October 17-21, 2022. The inspection, performed under FDA guidelines for biological and drug manufacturing (CPGM 7345.848 and 7356.002), identified two main observations, resulting in the issuance of an FDA Form 483.

The first critical violation highlighted unsanitary conditions within the manufacturing facility, specifically a packaging room (Room 126). Inspectors observed dirt on baseboards, rust and brown stains on walls, and a water-stained ceiling tile directly above packaging equipment during the labeling and packaging of Alprolix®. This indicated a failure to maintain buildings in a clean and sanitary state, as required by 21 CFR 211.56(a).

The second observation noted that quality procedures were not fully adhered to. Deficiencies were found in the effectiveness checks for Corrective and Preventive Actions (CAPAs) related to deviations and complaints. Additionally, a change control record for combining freezers was not thoroughly assessed for impact. Packaging Coordinators, LLC informed the FDA that they intend to respond to these observations in writing within 15 business days, outlining their planned corrective measures.