FDA WARNING_LETTER - Oskri Corp. - June 19, 2013

The FDA conducted an inspection of Oskri Corporation's snack food manufacturing facility in Lake Mills, Wisconsin, on multiple dates in May and June 2013. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR 110), causing products to be adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions. Additionally, several products were found to be adulterated (section 402(c)) or misbranded (section 403) due to labeling deficiencies (21 CFR 101).

Key violations include: 1. **Failure to maintain equipment and utensils in acceptable condition (21 CFR 110.80(b)(1)):** Observed cross-contamination risks with allergens (tree nuts, milk, soy) due to inadequate cleaning and sanitizing between product runs, significant food debris on processing tables, uncleaned mixer paddle assembly, and residue on packaging equipment. Utensils labeled "clean" had visible food residue. The firm's response regarding allergen sequencing and chemical training was deemed inadequate. 2. **Failure to protect against extraneous material (21 CFR 110.80(b)(8)):** No systems in place to prevent metal inclusion. Multiple consumer complaints of metal shavings/pieces, traced to damaged copper mixing bowls, resulted