FDA EIR - AndersonBrecon Inc. - December 05, 2018

The Food and Drug Administration conducted an inspection of Anderson Brecon, Inc. dba PCI of Illinois in Rockford, IL, between December 4 and December 5, 2018. This cGMP (current Good Manufacturing Practices) inspection was performed under the Team Biologics FY’2019 work plan, adhering to Compliance Program 7345.848 for biological drug products, overseen by CBER (Center for Biologics Evaluation and Research). The inspection primarily evaluated the company's Quality System and Packaging and Labeling System for a CBER-licensed sterile, lyophilized product, for which Anderson Brecon performs primary and secondary packaging.

Although no formal FDA 483 observations were issued, two key deficiencies were verbally communicated to the firm's management. The main issues concerned operator training for in-process finished goods inspection. Specifically, there was an absence of a documented reference library illustrating critical, major, or minor visual defects, which is crucial for consistent quality assessment. Furthermore, the on-the-job training provided to these operators was not formally documented. While not constituting regulatory violations that trigger an FDA 483, these discussions indicate a need for Anderson Brecon to enhance its training programs and associated documentation to strengthen quality control within its packaging and labeling operations.