FDA 483 - Crystal Creamery Inc. - September 12, 2025

During an inspection conducted from September 3 to September 12, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Crystal Creamery, detailing significant observations related to their manufacturing practices. The inspection revealed the company failed to fully implement its corrective action procedures after Salmonella contamination was detected in a ready-to-eat non-fat dry milk product. Notably, the identified Salmonella strain matched one previously found at the facility in 2008, and the company did not adequately assess other products processed on the same equipment during the contamination event. Further observations included deficiencies in equipment design and maintenance. Specifically, gaskets on the spray dryer's clean-in-place (CIP) plugs were observed leaking powder product, posing a potential contamination risk to the ready-to-eat product. Additionally, the facility exhibited inadequate sanitary accommodations; a dedicated handwash sink within the spray dryer's processing area was rendered unusable due to being filled with equipment parts, preventing proper hand hygiene for employees handling food contact surfaces. These observations, documented under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, indicate conditions that could lead to products being prepared or held under insanitary circumstances. Crystal Creamery is required to promptly evaluate these findings and implement comprehensive corrective and preventive actions to ensure compliance and prevent future contamination, submitting their responses to the FDA.