Posted March 2, 2013

FDA Finds Manufacturing Violations At NSF-Certified Supplement Facility

The FDA recently warned dietary supplement manufacturer Beehive Botanicals, Inc. of numerous Current Good Manufacturing Practices (CGMPs) violations, despite the fact that the company had been inspected and registered as CGMP compliant by NSF International, an independent auditing company that many dietary supplement manufacturers rely on to assess their compliance with federal regulations.

The FDA’s inspection of Beehive Botanicals’ manufacturing facility uncovered violations including failure to establish product specifications for the identity, purity, strength, and composition for each dietary supplement, failure to maintain adequate Master Manufacturing Records and other documentation, and failure to meet federal requirements for approving and releasing a finished batch of dietary supplements.

The violations caused the FDA to find Beehive’s products, such as Bone Health, with calcium and vitamin D ingredients, to be adulterated.

(See ConsumerLab.com’s Reviews of Calcium Supplements and Vitamin D Supplements for tests of related products).

The FDA noted that Beehive’s initial attempts to correct these violations were inadequate, and was allowing the company 15 days to take further steps to rectify the situation.

The FDA also recently issued a manufacturing violations warning to supplement company Capco Custom Packaging Inc. This company appears to be related to Capco Labs, which is also listed as CGMP compliant on NSF International’s registry. Both are located at the same address.

An article about these recent situations, including an interview with the general manager of NSF’s dietary supplement certification program, appears in NutraIngredients-USA.com.

For more information about the FDA’s warning, use the link below.