FDA WARNING_LETTER - MCACO, LTD - December 07, 2021

The FDA issued a Warning Letter to Mr. Aguayo following an inspection of their facility at 1610 W. Polo Rd, Grand Prairie, TX, from November 4, 2021, to December 7, 2021. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering their products adulterated under section 402(g)(1) of the Act.

Key violations include: 1. Failure to establish product specifications for identity, purity, strength, and composition of finished dietary supplements (21 CFR 111.70(e)). 2. Failure to establish component specifications to ensure purity, strength, and composition of dietary supplements (21 CFR 111.70(b)(2)). 3. Failure to qualify suppliers by confirming the reliability of their certificates of analysis for components like Turmeric Root Powder and Milk Thistle Seed Extract (21 CFR 111.75(a)(2)(ii)(A)). 4. Failure to verify that laboratory examination and testing methodologies, such as IR testing for finished products, are appropriate for their intended use (21 CFR 111.320(a)). 5. Failure to establish Master Manufacturing Records (MMRs) that include all required components (21 CFR 111.