FDA 483 - LS Promotions Inc. - June 13, 2024

An FDA inspection conducted on June 12-13, 2024, at LS Promotions Inc., a repacker located in Ronkonkoma, NY, identified significant deficiencies in the firm's sanitation practices. The primary observation noted was the failure to clean and sanitize utensils and equipment in a manner that prevents allergen cross-contact. Specifically, an FDA investigator observed an employee cleaning food-contact equipment, including a stainless-steel bowl, with detergent in a three-compartment sink but without subsequent sanitization. These items were then prepared for use on a filling and packing machine. This equipment is used for both coffee (non-dairy) and hot chocolate (contains milk), as well as ready-to-eat chewing gum, posing a direct risk of allergen contamination. Furthermore, it was confirmed by management that employees were not currently using sanitizer for any equipment or utensils. These findings were documented on an FDA Form 483, issued pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act. The document highlights conditions that may lead to products being prepared or held under unsanitary conditions, potentially rendering them injurious to health. LS Promotions Inc. is now expected to address these serious sanitation deficiencies and implement robust corrective actions to ensure proper cleaning, sanitization, and allergen control procedures are consistently followed.