FDA WARNING_LETTER - Carol Bond Health Foods - September 29, 2017

The FDA inspected Carol Bond Health Foods, Inc. from September 15-29, 2017, identifying serious cGMP violations for dietary supplements, rendering products adulterated under 21 U.S.C. § 342(g)(1). Additionally, products like ThistleX, Vinpocetine, Dolomite, Lipo Fat Fighter, and Injuv are deemed unapproved new drugs under 21 U.S.C. § 321(g)(1)(B) due to disease treatment claims on labels and the website, violating 21 U.S.C. §§ 331(d), 355(a). These drug products are also misbranded under 21 U.S.C. § 352(f)(1) for lacking adequate directions for use, violating 21 U.S.C. § 331(a).

Specific cGMP violations include failure to establish written procedures for quality control operations (21 CFR 111.103, 111.140(b)(1)), collect and hold reserve samples (21 CFR 111.83(a)), establish procedures for returned dietary supplements (21 CFR 111.503), establish procedures for product complaints (21 CFR 111.553, 111.