Albanese Confectionery Group, Inc. – FDA EIR, May 5, 2017

This FDA inspection of Albanese Confectionery Group, Inc., conducted from April 24 to May 5, 2017, focused on their dietary supplement gummy manufacturing operations. The inspection was performed under the Compliance Program Guidance Manual 7321.008 for Dietary Supplements, aligning with 21 CFR Part 111 regulations. The inspection identified numerous deficiencies, resulting in a 15-point FDA Form 483, including repeat observations from a prior 2014 inspection. Key violations involved the company

s Master Manufacturing Records (MMRs), which were found to be deficient in several areas: they lacked specific instructions for each batch size, failed to identify critical control points and specifications for product quality (e.g., weight, color, foreign material), omitted sampling procedures, and did not include corrective action plans for when specifications were not met. Additionally, batch production records did not consistently adhere to the MMRs, failing to record essential processing parameters like temperatures and mixing times, and lacking statements of actual and theoretical yield. Other issues included inadequate verification of component weights and additions, insufficient supplier qualification, improper storage of components, and deficiencies in procedures for returned dietary supplements. Calibration documentation also required improvement. Following the inspection, management verbally committed to submitting a comprehensive written response to the FDA Form 483, detailing their planned corrective actions to address these significant regulatory observations.