Consolidated Marketing Unlimited, Inc. – FDA Warning Letter, May 4, 2012

On April 23-May 4, 2012, an FDA inspection of Consolidated Marketing Unlimited, Inc. in Sunrise, FL, revealed serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111). The firm manufactures and distributes products like Cantron, GH-3, and Hydrazine Sulfate. These violations render their dietary supplements adulterated under section 402(g)(1) of the Act.

Key violations include: * **Failure to verify component identity:** No testing for dietary ingredients like Inositol, Potassium Hydroxide, and Hydrazine Sulfate before use. (21 CFR 111.75(a)(1)(i)) * **Lack of master manufacturing records:** Generic "Manufacturing and Production order" forms were used instead of specific master manufacturing records for each unique formulation and batch size. (21 CFR 111.205(a)) * **No calibration procedures:** Instruments and controls (e.g., thermometers, scales) were not calibrated, and pH buffers were expired. No written calibration procedures existed. (21 CFR 111.25(a)) * **Inadequate production and process controls:** Absence of written procedures for manufacturing, packaging, labeling, and holding operations. (21 CFR 111.55) * **Failure to establish specifications:** No specifications