mdk enterprises, inc – FDA Warning Letter, May 15, 2012

On September 5, 2012, the FDA issued a Warning Letter to MDK Enterprises, Inc. dba Maui Jelly Factory following an inspection from May 5-15, 2012, at their Wailuku, Hawaii facility. The inspection revealed significant deviations from Acidified Food regulations (21 CFR Part 108 and Part 114) for their "Mango Butter" product, classifying it as adulterated under Section 402(a)(4) of the Act due to insanitary conditions.

Key violations include: 1. **Failure to File Scheduled Process (21 CFR 108.25(c)(2)):** The firm did not provide FDA with information on the scheduled process for Mango Butter, including heat processing and control of pH, salt, sugar, and preservative levels. 2. **Inadequate pH Monitoring (21 CFR 114.80(a)(2)):** The firm failed to monitor the final equilibrium pH of Mango Butter, instead measuring in-process pH, which frequently exceeded 4.6. Products with high in-process pH were shipped without retesting for equilibrium pH. 3. **Lack of Identifying Codes (21 CFR 114.80(b)):** Containers of Mango Butter lacked required identifying codes specifying the establishment, product, year, date, and packing period.

The company's June