FDA WARNING_LETTER - Rock Solid Nutrition, LLC - July 12, 2016

On July 8-12, 2016, the FDA inspected Rock Solid Nutrition, LLC's dietary supplement facility in Omaha, Nebraska, collecting labels for "Whey Isolate," "Pre-Pump," and "Strength Test." The inspection revealed serious violations of the Federal Food, Drug, and Cosmetic Act, rendering their products adulterated and misbranded.

The company failed to establish and follow written procedures for quality control operations (21 CFR 111.103), including ensuring quality of incoming products, collecting reserve samples, meeting specifications, and reviewing manufacturing records. Their submitted response was deemed inadequate. As a distributor, Rock Solid Nutrition is ultimately responsible for ensuring CGMP compliance, even with contract manufacturers.

They also failed to establish and follow written procedures for holding and distributing operations (21 CFR 111.453), lacking details on appropriate storage conditions, reserve sample handling, contamination protection, and record-keeping.

Furthermore, "Whey Isolate," "Pre-Pump," and "Strength Test" were misbranded. Serving sizes were incorrect or not in common household measures (21 CFR 101.9(b), 101.36(b)(1), 101.12(b)). Nutrition information presentation was non-compliant (21 CFR 101.36), with missing source ingredients, incorrect segregation of dietary ingredients, and improper use of symbols