FDA EIR - The Elderberry Co., LLC - November 03, 2021

An FDA inspection of The Elderberry Co., LLC, based in New Albany, IN, was conducted from November 1-3, 2021. This inspection served as a follow-up to a previous Warning Letter and evaluated the firm's compliance with regulatory frameworks including 21 CFR Part 117 (Preventive Controls for Human Food) and guidelines for food labeling and sanitary food operations (CPGM 7321.005, CPGM 7303.040), with a focus on Elderberry Syrup manufacturing. Though no formal Form FDA 483 (Inspectional Observations) was issued, several critical issues were identified and discussed. These included the firm's failure to identify significant biological hazards like Clostridium botulinum, Salmonella spp., and Listeria monocytogenes in their hazard analysis. Other concerns noted were sanitation deficiencies such as the lack of an air gap between a chiller discharge hose and a floor drain, unlabeled raw ingredient containers, unlabeled spray bottles and product buckets, and product buckets stored on the floor. Furthermore, the firm's documentation of food safety complaint investigations was inadequate, and their recall procedures did not include notifying regulatory agencies. The absence of maintained water quality reports was also cited. Management committed to addressing these deficiencies before the next inspection.