FDA WARNING_LETTER - The Ben Heggy Candy Company - April 18, 2022

The FDA inspected a candy manufacturing facility from March 11 to April 18, 2022, finding serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). The firm manufactures ready-to-eat chocolate-covered candies.

The FDA determined the candy products are adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. The firm also violated 21 U.S.C. § 331(uu) by failing to comply with preventive controls. Additionally, significant labeling violations under 21 CFR Part 101 cause products to be misbranded per 21 U.S.C. § 343.

Key violations include: - **Hazard Analysis (21 CFR 117.130(a)(1)):** Failure to identify and evaluate egg and wheat as allergen hazards requiring preventive controls, and inadequate cleaning procedures for shared equipment leading to allergen cross-contact. - **Allergen Controls (21 CFR 117.135(c)(2)(i)):** Inadequate procedures for preventing cross-contact from walnuts and lack of written corrective action procedures for allergen controls. - **Environmental Monitoring (21 CFR 117.165(b)(3)):**