FDA WARNING_LETTER - Dandy Day Corporation - April 08, 2014

On April 2-8, 2014, the FDA inspected Dandy Day Corporation's manufacturing facility, identifying serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). These violations render their dietary supplement products adulterated under 21 U.S.C. § 342(g)(1).

Additionally, a December 2014 review of Dandy Day's website, www.dandyday.com, revealed that several products (Aloe Lip Balm, Liniment, Lotion, New Feet, Aloe Pearl, Alfalo, Aloespring, Crave Away, Original Supreme Energy, Ener ?G?, Can G, Flora G, Flora G Plus, and Garolic) are promoted with therapeutic claims, classifying them as unapproved new drugs under 21 U.S.C. § 321(g)(1)(B) and § 321(p). These products are also misbranded under 21 U.S.C. § 352(f)(1) due to inadequate directions for use.

Key CGMP violations include: 1. Failure to establish quality control operations for product complaints, specifically reviewing and approving investigation decisions and findings (21 CFR 111.135). 2. Failure to establish specifications for components, finished products, and received products for packaging/label