Reaction Nutrition, L.L.C. – FDA Warning Letter, Dec 20, 2011

The FDA conducted an inspection of Reaction Nutrition, L.L.C.'s dietary supplement facility from November 29 to December 20, 2011, identifying significant Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 111, rendering products adulterated.

Key violations include: 1. **Release of Non-Conforming Products:** Quality control released batches (e.g., Reaction Nutrition Velocity, ProRx Thermolean) that did not meet product specifications, such as missing ingredients or incorrect capsule components/weights. 2. **Lack of Master Manufacturing Records (MMRs):** No MMRs were prepared for softgel dietary supplement products. 3. **Inadequate MMR Content:** MMRs for products like Reaction Nutrition Velocity and ProRx Thermolean lacked required information, including representative labels and proper specifications for manufacturing steps (e.g., blend time upper limits). 4. **Failure to Verify Finished Product Specifications:** The firm did not perform finished product testing to verify identity, purity, strength, and composition for every batch, as required. 5. **Lack of Written Manufacturing Procedures:** No written procedures for blending processes were established or followed. 6. **No Procedures for Returned Dietary Supplements:** The firm lacked written procedures for handling returned dietary supplements.

Additionally, the "Live Capsules" product was deemed an unapproved new drug and misbranded due to therapeutic claims (e.g.,