FDA 483 - Rx Vitamins, Inc - November 07, 2016

Rx Vitamins, Inc. in Elmsford, NY, an own label manufacturer of dietary supplements, was cited with four observations during an FDA inspection. The firm failed to ensure product specifications were met for co-manufactured dietary supplements, lacked written procedures for quality control operations and product complaint investigations for human supplements, and did not retain required reserve samples. These issues indicate significant deficiencies in quality control and documentation practices.