FDA WARNING_LETTER - ABH Nature's Products, Inc. - June 12, 2012

The FDA inspected ABH Nature’s Products, Inc.’s dietary supplement manufacturing facility in Farmingdale, NY, from June 6-12, 2012, revealing serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111) and labeling requirements (21 CFR Part 101). This renders Cal-Mag and Raspberry Ketone products adulterated and misbranded, respectively. CGMP violations included failure to establish and follow laboratory control processes for standard reference materials (21 CFR 111.315(d)), failure to qualify component suppliers by confirming certificates of analysis (21 CFR 111.75(a)(2)(ii)(A)), failure to verify finished batch specifications for Cal-Mag (21 CFR 111.75(c)), and failure to monitor in-process points to ensure quality (21 CFR 111.75(b)(1)). Raspberry Ketones was misbranded for failing to declare "dietary supplement" as part of the statement of identity (21 CFR 101.3(g)), omitting the manufacturer/packer/distributor's name and place of business (21 CFR 101.5), and lacking a domestic address or phone number for serious adverse event reporting (21 U.S.C. § 343(y)). The firm's June 25, 2012, response to the FDA 483 was deemed inadequate, lacking sufficient documentation or failing to fully address the issues. Additionally, Cal-Mag tablets showed Magnesium Oxide content at 98.1% of the label claim, potentially leading to misbranding under 21 CFR 101.9(g)(4)(i). ABH Nature’s Products must provide a written response within 15 working days detailing corrective actions and prevention measures, with supporting documentation. Failure to comply may result in legal action and re-inspection fees.