FDA WARNING_LETTER - Oh So Clean, Inc. - August 30, 2010

On April 18, 2011, the FDA issued a Warning Letter to Oh So Clean, Inc. dba CleanWell Company following an inspection from August 16-30, 2010. The inspection revealed significant violations concerning unapproved new drugs and Current Good Manufacturing Practice (CGMP) regulations.

CleanWell's products, including "CleanWell All-Natural Foaming Hand Sanitizer," "CleanWell All-Natural Hand Sanitizer," "CleanWell All-Natural Hand Sanitizing Wipes," and "CleanWell All-Natural Antibacterial Foaming Handsoap," were deemed unapproved new drugs under section 505(a) of the Act and misbranded under section 502(e). The products' labeling claimed "essential plant oils" (beyond the listed Thymol) as active antimicrobial ingredients, making unproven claims like killing MRSA, Salmonella, Staph, and E. coli. These claims and formulations are not generally recognized as safe and effective, nor are they covered by any OTC monograph or eligible for the OTC Drug Review without a time and extent application. Furthermore, the labels failed to list all active ingredients, leading to misbranding.

CGMP violations included the Quality Control Unit's (QCU) failure to establish and follow written responsibilities and procedures (21 CFR 211.22(d)), specifically lacking a procedure for Out-of-Specification (OOS)