FDA WARNING_LETTER - Hsu S Ginseng Enterprises - December 03, 2010

The FDA issued a Warning Letter to Hsu's Ginseng Enterprises, Inc. following an inspection from November 30 to December 3, 2010, at their Wausau, Wisconsin facility. A sample of their "Root to Health, American Ginseng, Herbal Supplement" was found to be adulterated under 21 U.S.C. § 342(a)(2)(B) due to the presence of unsafe pesticide chemical residues, Chlorpyrifos and Pentachlorobenzonitrile, for which no tolerance or exemption exists (21 U.S.C. § 346a).

The inspection also identified several deficiencies in Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements (21 CFR Part 111). These included a lack of finished product release specifications for ginseng encapsulated products regarding identity, strength, purity, composition, or contamination limits (21 CFR 111.70(e)). Training records were incomplete, missing details such as who was trained, topics, trainer, course length, and successful completion (21 CFR 111.12(c)). Additionally, batch records for American Ginseng and Bee Pollen & American Ginseng supplements were unavailable (21 CFR 111.610(a) and (b)). The firm was also cited for using unsupported expiration dates on product labels.

Hsu's Ginseng is required to take prompt corrective action and notify the FDA in writing within 15 working days, detailing steps taken to prevent recurrence and providing supporting documentation. Failure to comply may result in regulatory actions, including product seizure or injunction.