FDA EIR - Albanese Confectionery Group, Inc. - October 24, 2018

An FDA inspection of Albanese Confectionery Group, Inc. in Merrillville, IN, was conducted from August 20 to October 24, 2018. This comprehensive compliance inspection, performed under Domestic Food Safety and Dietary Supplements regulatory programs, served as a follow-up to previous inspections in 2017.

During the prior 2017 inspections, the company received a 3-point FDA 483 for food safety concerns, including inadequate protection of work-in-progress, insufficient cleaning of food-contact surfaces, and improper storage of finished food. A separate 15-point FDA 483 was issued for numerous dietary supplement good manufacturing practice (GMP) violations, primarily related to Master Manufacturing Records (MMRs) and Batch Production Records (BPRs), encompassing issues from inaccurate formulations and lack of specifications to inadequate calibration and supplier qualification.

Notably, during the current 2018 inspection, an FDA 483 was not issued, indicating substantial voluntary corrective actions by Albanese Confectionery. Key issues discussed included uncovered gummi kettles, insufficient root cause analysis in MMR corrective actions, improper conversion of materials between dietary supplement batches, and inconsistent half-batch formulations leading to ingredient discrepancies. Production record documentation errors were also noted.

The company implemented extensive changes, such as designing kettle covers, revising MMR procedures to include root cause analysis and expert consultation, discontinuing problematic material conversion and half-batch practices, and updating records for accurate yields and cleaning logs. They also enhanced allergen controls, developed comprehensive sampling procedures, improved calibration documentation, and established robust supplier qualification processes. These actions demonstrate a significant commitment to regulatory compliance and improved quality management.