Biotek, Inc. – FDA Warning Letter, Aug 24, 2017

On August 14-24, 2017, the FDA inspected Biotek Inc.'s facility in Layton, UT, and subsequently reviewed product labeling. The inspection revealed serious violations of the Federal Food, Drug and Cosmetic Act.

Biotek's products Bio-35, Lipotropic Formula, and ProCal are deemed unapproved new drugs due to therapeutic claims on their website (e.g., "Immune system is improved helping to combat stress and disease," "Improves Triglyceride Level in Blood," "To help with Restless Leg Syndrome or Muscle Cramps"). These products are not generally recognized as safe and effective, requiring prior FDA approval. Pro-Cal is also misbranded as it lacks adequate directions for layperson use, being intended for conditions requiring professional supervision.

Additionally, numerous Current Good Manufacturing Practice (CGMP) violations for dietary supplements were identified, rendering products adulterated. Biotek failed to: * Establish and follow written quality control procedures (21 CFR 111.103). * Implement production and process controls for packaging, labeling, and holding, leading to label inaccuracies (e.g., undeclared soy in Bio-35, missing ingredients on Lipotropic Formula, inconsistent Pro-Cal labels) (21 CFR 111.55). * Establish specifications for incoming product identification (21 CFR 111.70(f)). * Establish