FDA WARNING_LETTER - Bio-Recovery Inc. - May 17, 2013

An FDA inspection of Bio-Recovery, Inc. (Minneapolis, MN) in May 2013 identified significant violations. The firm, a dietary supplement distributor, was cited for marketing unapproved new drugs and numerous Current Good Manufacturing Practice (CGMP) deficiencies. Products like Bio-Lithium, Niacinamide, Bio-Aminos, and CoQ-10 are considered unapproved new drugs (21 U.S.C. § 321(g)(1)(B), § 321(p)) due to therapeutic claims on the company's website for conditions such as alcoholism, cancer, and heart disorders. These products are also misbranded (21 U.S.C. § 352(f)(1)) lacking adequate directions for use. Furthermore, the firm's dietary supplements are adulterated (21 U.S.C. § 342(g)(1)) due to CGMP violations (21 CFR Part 111). Deficiencies include failing to identify quality control personnel and establish written QC procedures (21 CFR 111.12(b), 111.103, 111.140(b)(1)), not collecting reserve samples (21 CFR 111.83(a)), and lacking written procedures for packaging/labeling (21 CFR 111.403), holding/distributing (21 CFR 111.453), returned products (21 CFR 111.503), and product complaints (21 CFR 111.553). The firm's stated unawareness of regulations and lack of records underscore systemic quality control issues. As the distributor, Bio-Recovery holds ultimate responsibility for CGMP compliance. The FDA requires a written response within 15 working days detailing corrective actions to prevent further regulatory action, including potential seizure, injunction, and re-inspection fees.