Albanese Confectionery Group, Inc. – FDA EIR, Apr 13, 2022

An FDA inspection of Albanese Confectionery Group, Inc., a manufacturer of confectioneries and dietary supplement gummies in Merrillville, IN, was conducted from April 5 to April 13, 2022. This comprehensive inspection, prompted by a consumer complaint, assessed compliance with regulatory frameworks including 21 CFR Part 117 (Current Good Manufacturing Practice and Preventive Controls for Human Food) and 21 CFR Part 111 (Dietary Supplements).

During the inspection, the FDA issued a Form 483 for two significant observations. Firstly, the company failed to maintain its physical plant in a clean and sanitary condition, evidenced by manufacturing residual build-up on pipes above equipment, a foreign particulate on a stainless-steel grate, and a rusted pipe cover above processing areas. Secondly, Albanese Confectionery Group, Inc. did not provide required records for review and copying, specifically documentation related to allergen changeover procedures, which included missing quality control forms.

Additional concerns discussed with management included water dripping from a high-pressure hose near raw materials, exposed in-process confectionery conveyed too close to the production floor, and inadequate employee hygiene practices (e.g., wearing overcoats outside production areas and improper hairnet use). The inspection also referenced two recent recalls: a March 2022 Class 1 recall for undeclared allergens in Dark Chocolate Espresso Beans, and an August 2021 Class II recall for misbranded Mini Gummi Butterflies due to an undeclared dietary supplement.

Management committed to addressing the dripping water and employee hygiene through investigation and training. They acknowledged the exposed confectionery issue and stated they are working on corrections. The firm indicated they would formally respond to the FDA's observations within fifteen days.