In Brief: Private Formulations
This article was originally published in The Tan Sheet
Executive Summary
Private Formulations: Halts production of Medicine Shoppe Gas Relief Tab 24X100 and Simethicone 80 after 750 cases of the product were seized by the St. Louis District Attorney's office in November. FDA requested the seizure after it found that Edison, N.J.-based Private Formulations, the product manufacturer, failed to meet good manufacturing practices. Private Formulations was charged with failure to ensure proper validation of the product, failure to use appropriate testing procedures, failure to validate its test methods, and failure to adhere to an adequate stability program. Medicine Shoppe voluntarily withheld shipment of the product in mid-September upon FDA's request. The pills, priced at more than $28,500, were seized later at a public warehouse used by Medicine Shoppe...