SPI Pharma, Inc. – FDA EIR, Aug 24, 2016

An FDA cGMP inspection of SPI Pharma, Inc. in Lewes, Delaware, was conducted from August 23 to August 24, 2016. The inspection focused on the facility's production of Active Pharmaceutical Ingredients (APIs) for Over-the-Counter (OTC) drugs, specifically Aluminum Hydroxide Gel, Magnesium Hydroxide Paste, Aluminum Magnesium Sorbitol Co-blend, and Magaldrate. This assessment followed established regulatory frameworks, including Compliance Program 7356.002F for API process inspections and ICH-Q7 guidelines. The comprehensive inspection covered various critical areas of operation, such as process validation, batch record review, analytical testing methods, stability programs, quality control unit functions, CAPA systems, investigations, deviation handling, change controls, facility and equipment qualifications, and employee training. A key finding of this inspection was that no significant violations or deficiencies were identified. Consequently, no Form FDA 483 was issued at the conclusion of the inspection. This outcome signifies that the facility was found to be operating in satisfactory compliance with regulatory requirements, and therefore, no mandatory corrective actions were stipulated by the FDA.