FDA WARNING_LETTER - Global Source Management & Consulting, Inc - March 15, 2012

The FDA conducted an inspection of Global Source Management & Consulting from January 19 to March 15, 2012, identifying serious violations of the Federal Food, Drug, and Cosmetic Act.

Several products, including Scientific Joint Program capsules and Alpha Lipoic Acid, were deemed unapproved new drugs due to disease treatment/prevention claims (e.g., "melt arthritis pain away," "increase sensitivity to insulin"). These products are considered "new drugs" under section 201(p) and require FDA approval, which they lack. Additionally, some products were misbranded under section 502(f)(1) for lacking adequate directions for layperson use.

The company's dietary supplements were found to be adulterated under 21 CFR Part 111 (CGMP regulations). Violations included: * Failure to package and label dietary supplements according to a Master Manufacturing Record (MMR), as no MMR existed (21 CFR 111.415). * Failure to establish specifications for packaging and labeling (21 CFR 111.70(f)). * Absence of written procedures for quality control operations (21 CFR 111.103). * Incomplete batch production records, lacking equipment identity, cleaning dates, label quantities, and test results (21 CFR 111.255(b), 1