FDA WARNING_LETTER - ProNatural Nutrition, LLC - October 30, 2012

On October 25-30, 2012, the FDA inspected ProNatural Nutrition, LLC, a dietary supplement contract manufacturer. The inspection revealed the firm promoted products with drug claims, causing them to be unapproved new drugs and misbranded. Examples include claims like "healing to cells and tissue," "non-Toxic Antibiotic," and uses for "Colds...Sinus...Sore Throat...Fungus...Ear Infections...Allergies." These products are not generally recognized as safe and effective, lacking FDA approval. Additionally, some products intended for topical use (e.g., colloidal silver products) are not dietary supplements and are considered unapproved new drugs and misbranded.

The inspection also found serious violations of dietary supplement CGMP regulations (21 CFR Part 111), rendering products adulterated. Deficiencies included: 1. Failure to establish specifications for manufacturing processes, components (identity, purity, strength, composition, contamination limits), labeling, packaging, and finished products. 2. Failure to determine if component specifications were met, lacking documentation for testing or supplier qualification. 3. Absence of written procedures for quality control operations, including sample collection, laboratory operations, material review, equipment, components, master manufacturing records, batch production records, and returned products. 4. Failure to prepare and follow written master manufacturing records for each unique formulation and batch size. 5. Incomplete batch production records, missing information on equipment identity,