FDA EIR - Jasper Products, L.L.C. - June 09, 2023

An unannounced FDA inspection of Jasper Products, L.L.C., located in Joplin, MO, was conducted from June 6 to June 9, 2023. The inspection, initiated by a consumer complaint, revealed one primary observation despite no FDA Form 483 being issued. The main issue identified under 21 CFR 117.130(a)(1) was the company's hazard analysis failing to adequately identify allergen cross-contact as a hazard requiring a preventive control at all applicable processing steps, specifically from batching through packaging, where shared equipment is used for products with different allergens. Additionally, the firm's procedures for evaluating and tracking consumer complaints were deemed insufficient to accurately assess the likelihood of hazards in finished products. Discussions also highlighted the need to clarify their written recall plan concerning effectiveness checks and disposition of recalled food. Jasper Products was informed of their responsibilities to revise their hazard analysis to include allergen cross-contact at all relevant stages and to improve their complaint handling and tracking systems. Adherence to the Food Drug and Cosmetic (FD&C) Act was emphasized for continued compliance and export eligibility.