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Posted May 3, 2013

Maker of Probiotic, Iron and Folic Acid Supplements Warned For Manufacturing Violations

On April 17, 2013, the FDA issued a warning letter to Hillestad Pharmaceuticals USA, Inc. following a facility inspection which found the company's products, including Acidophilus with Pectin, Iron Tone Plus and Folic Acid Tablets, were found to be adulterated because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMPs) requirements for dietary supplements.

Violations included failure to use appropriate methods or reference standard materials for identity testing of dietary supplement ingredients and failure to verify that finished batches of dietary supplements meet product specifications for identity, purity, strength, composition, and for limits on those types of contamination that may adulterate finished batches of the dietary supplements.

See's Reviews of Probiotic Supplements, Iron Supplements and Folic Acid Supplements for tests of related products.

To read the FDA's warning letter, use the link below.