FDA 483 - Prescription Alternatives, Inc. - November 16, 2018

An FDA inspection of Prescription Alternatives, Inc., a producer of sterile and non-sterile drug products, was conducted from November 13-16, 2018. The inspection identified several critical deficiencies in the company's manufacturing and quality control processes. For sterile ophthalmic drug products intended for animals, operations were performed in an uncontrolled environment on an open pharmacy counter, lacking proper segregation to prevent contamination. Personnel involved in sterile production did not wear essential protective attire, such as sterile gowns, hairnets, or gloves. Furthermore, the firm had not established written procedures to prevent microbiological contamination for these sterile products, and the final containers/closures used were neither sterile nor depyrogenated prior to use. Additionally, the 180-day beyond-use dates assigned to sterile products were not supported by a written stability testing program or sterility data. For human drug products, including oral suspensions and solutions, non-pharmaceutical grade water was used during compounding. These observations highlight a significant need for comprehensive corrective actions to ensure drug product quality, safety, and compliance with current good manufacturing practices.