ABC Compounding Company Inc – FDA Warning Letter, Apr 30, 2019

The FDA issued a Warning Letter to ABC Compounding Co., Inc. on April 18, 2019, regarding inaccurate listing information for their product, Santi Wash Antiseptic Hand Wash, NDC 62257-275. The FDA had previously notified the company of this deficiency on November 15, 2018, and removed the listing data from the online NDC Directory on December 30, 2018, due to unaddressed issues.

The core violation is a discrepancy in the active ingredient statement: the electronic listing file identifies povidone-iodine 5 mg in 1 ml, while the Drug Facts labeling states benzethonium chloride USP 0.2%. This violates Section 510(j) of the FD&C Act and 21 CFR part 207, which require accurate listing of pharmaceutical ingredients. This failure constitutes a prohibited act under Section 301(p) and misbrands the product under Section 502(o), making its introduction into interstate commerce a prohibited act under Section 301(a).

The FDA requires a written response within fifteen working days detailing specific corrective actions, an explanation of steps to prevent recurrence, and supporting documentation. The company is also reminded that OTC drug products must comply with applicable monographs, 21 CFR 330.1, and all requirements of Section 502 of the FD