Latest FDA Warning Letters
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Green Supreme, Inc. West Middlesex, PA (1/15). Reviewed Web site at www.greensupreme.net 11/2015. Misbranded: The claims on the Web site establish that the products are drugs. For example it states on the Web site’s “Home Page”: “Barley Grass has the ability to counteract inflammation…Our Products are Recommended by Bill Henderson in his book ‘Cancer Free Cancer Patients…” And on the “More Info tab” which is within the Products tab: “The Young Green Leaves of Barley: Barley Power…Powerful antioxidants, beta carotene, and chlorophyll to protect against degenerative diseases: Cancer, Arthritis and others…”, etc. (Green Supreme with Barley Power, Green Supreme with Chromium Picolinate, Green Supreme plus Cayenne, Green Supreme Petal Soft, Green Supreme Super Prostate); FDCA 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm482115.htm
IsoLux, LLC. Naples, FL (1/8). Inspected 11/4-6/15. QSR deviations, adulterated: The firm conducted CAPA activities related to spot uniformity and homogeneity of its fiber optic cable illumination and misalignment of its Isovu Headlight Camera System in 3/2011. The records for these CAPAs did not include documentation related to the investigation into underlying causes and verification or validation of the corrective action. This is a continued observation from previous inspections of 1/2010 and 8/2005. The firm relies on its suppliers’ Certificates of Analysis and a UL certification for incoming products, but these activities do not ensure that these incoming products meet product specifications, etc. (A/C-powered illuminators); FDCA 501(h), 21 CFR 820.100(a), 820.50, 820.80(b), 820.30(i)&(j)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm482382.htm
LAR Mfg., LLC Port Richey, FL (12/9/15). Inspected 8/31-9/1/15. QSR deviations, adulterated: The firm has not validated the following processes for the manufacture of its ceramic orthodontic brackets. It also failed establish procedures for the following requirements: analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, etc. (ceramic dental brackets); FDCA 501(h), 21 CFR 820.75(a), 820.100(a), 820.72(a), 820.80(a), 820.184, 820.70(a), 820.22, 820.20(e)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm482453.htm
Nutri-Dyn Midwest, Inc. Maple Plain, MN (1/15). Inspected 3/24, 25, 30, 31, 4/1 and 4/10. Unapproved new drugs, misbranded: The claims on the firm’s Web site and other product labeling establish that the products are drugs. For example, from the Web site www.nutri-dyn.com it states: Cardioauxin BP (Nutri-Dyn brand) – “…[P]atent pending grape seed product from Polyphenolics that reduces blood pressure by relaxing the blood vessels.” Also from the NutrihCG product brochure which promotes both the NutrihCG and the NutrihCG Reset product kits it states: “…[D]ecrease chronic diseases such as cardiovascular disease, diabetes, and cancer…positively affects neurologic disorders…”, etc. (Humanofort - Adrenal Support, Crave-Curb - Neurotransmitter Support, Ultimate Fat Burner-Metabolism Boost, Multi Caps - Vitamin and Mineral Support, Nutri-Dyn brand: D3 5000, Cardioauxin, Red Yeast Extract Extra Strength, etc.); FDCA 505(a), 502(f)(1), 503(b)(1)(A)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm482627.htm