FDA EIR - AndersonBrecon Inc. - June 10, 2022

An FDA inspection of AndersonBrecon Inc., operating as PCI of Illinois, a contract drug manufacturer specializing in packaging, labeling, and laboratory testing, was conducted from June 6 to June 10, 2022. The inspection, performed under Compliance Program 7356.002 for Drug Manufacturing, focused on the company's Quality, Laboratory Control, and Materials Systems. Notably, the inspection concluded without any significant violations or objectionable observations, and no FDA Form 483 was issued, indicating a generally compliant operation. Minor points discussed during the inspection included the firm's initial difficulty in providing comprehensive data from a previous Quality Management Information System transition, which was subsequently resolved. Additionally, the inspector noted a lack of clear visual indication for distinct areas within a clinical packaging suite, which management committed to correcting. Another administrative point raised was the need for the firm to revise its "Rules for Visitors" to explicitly permit FDA investigators to take photographs during inspections, which the firm acknowledged it would review and revise.