FDA WARNING_LETTER - SciLabs Nutraceuticals - August 14, 2012

On January 25, 2013, the FDA issued a Warning Letter to Scilabs Nutraceuticals, Inc. following an inspection from July 31 to August 14, 2012. The inspection revealed serious violations of dietary supplement Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering products adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, Duzoxin Secret to Slim, Punishment Nutrition, and Whey Protein Isolate products were found to be misbranded under Section 403(y) of the Act due to inadequate labeling.

Key violations include: * **Lack of Specifications:** Failure to establish required specifications for manufacturing processes (21 CFR 111.70) and to determine if specifications were met (21 CFR 111.73, 111.75). * **Component Identity Verification:** Failure to conduct identity testing for dietary ingredients (e.g., Instant Whey Protein, Glutamine) and to qualify suppliers for other components (e.g., Maltrin, Maltodextrin) (21 CFR 111.75(a)). The firm's response was deemed inadequate. * **Master Manufacturing Records (MMR):** Failure to prepare and follow written MMRs for each unique