Raw Deal, Inc – FDA Warning Letter, Mar 8, 2012

On October 4, 2012, the FDA issued a Warning Letter to Raw Deal, Inc. following an inspection from February 13 to March 8, 2012, at their Flanders, NJ facility. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), causing their "Mens Meal Replacement Blend" and "Woman Meal Replacement Blend" products to be adulterated under 21 U.S.C. § 342(g)(1).

Key violations include: * **Failure to verify dietary ingredient identity:** No testing was conducted on dietary ingredients prior to use in the "Mens Meal Replacement Blend" and "Woman Meal Replacement Blend" products (21 CFR 111.75(a)(1)(i)). * **Failure to verify finished product specifications:** No documentation showed finished product testing for identity, purity, strength, composition, or contamination limits (21 CFR 111.75(c)). * **Lack of Master Manufacturing Records:** No written master manufacturing records were prepared for the "Mens Meal Replacement Blend" and "Woman Meal Replacement Blend" products (21 CFR 111.205(a)). * **Lack of Batch Production Records:** No batch production records were prepared for the "Mens Meal Replacement Blend" and "Woman Meal Replacement Blend" products