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Posted October 17, 2012

Maker of Probiotic Supplement Warned for Manufacturing Violations

On September 28, 2012, the FDA issued a warning letter to dietary supplement manufacturer James G. Cole Inc., dba Maxam Nutraceutics, following an inspection of the company's facility which revealed violations of Current Good Manufacturing Practices (CGMPs) for manufacturing, packaging labeling and holding operations.

These violations cause the dietary supplements manufactured by Maxam Nutraceutics to be adulterated because they have been prepared, packed or held under conditions that do not meet CGMP regulations.

Violations included failing to establish product specifications such as identity, purity, strength and composition for the company's PCA Enzyme Supplement Plus Probiotics. This supplement contained the probiotics Lactobacillus bulgaricus, Acidophilus salivarius and Streptococcus thermophilus, and was promoted as "Nutritional Support for Natural Toxin and Waste Elimination."

See's Review of Probiotics for Adults, Children and Pets for tests of related products.

For more information about this warning letter, use the link below.