FDA 483 - Global Product Management, Inc. - March 07, 2011

An FDA inspection of Biotab Nutraceuticals, Inc. in Monrovia, CA, an own label dietary supplement distributor, revealed significant deficiencies in its quality control operations. The firm failed to establish and follow adequate written procedures for handling product complaints, ensuring product shelf life, and conducting sampling and inspection of dietary supplements. These observations indicate a lack of robust quality management systems necessary for compliance.