FDA WARNING_LETTER - Creation's Garden Natural Products, Inc. - March 06, 2012

The FDA conducted an inspection of Creation’s Garden Natural Products, Inc. facilities from January 30 to March 6, 2012, identifying significant violations of dietary supplement Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering products adulterated. The firm failed to verify finished product specifications (21 CFR 111.75(c)), qualify component suppliers (21 CFR 111.75(a)(2)(ii)(A), (C)), prevent contamination during manufacturing (21 CFR 111.365(a)), and use appropriate, cleanable utensils (21 CFR 111.27(a)). Additionally, the firm lacked data to support product expiration dates. Several products were found to be misbranded: a pediatric electrolyte solution had false/misleading nutrient content and undeclared preservatives (403(a), 403(i)(2), (k)); LunaSX Women’s Intimate contained an undeclared ingredient, DHEA (403(i)(2)). The LUNA SX Water Base Lubricant was deemed an adulterated and misbranded unapproved device (501(f)(1)(B), 502(o)), lacking PMA/IDE approval or 510(k) notification. Other lubricants were also identified as unapproved devices. Furthermore, website promotions for "Bowel & Parasite Cleanse" and "Parasite Cleanse" caused them to be unapproved new drugs (201(g)(1)(B), 201(p), 505(a)) and misbranded due to inadequate directions for use (502(f)(1)). The firm had received a prior warning for similar drug claims. Creation’s Garden must promptly correct all violations and respond within 15 working days with documented corrective actions to avoid further enforcement, including seizure, injunction, and reinspection fees.