SPI Pharma, Inc. – FDA EIR, Apr 29, 2019

An FDA surveillance cGMP inspection of SPI Pharma, Inc., located in Grand Haven, MI, was conducted from April 24-29, 2019. The inspection focused on the manufacturing of active pharmaceutical ingredients and excipients, specifically Mannitol, Acetaminophen (Actimask), and Calcium Carbonate (CM90), under the regulatory framework of Active Pharmaceutical Ingredient Process Inspection (CP 7356.002F). Significantly, no FDA Form 483, Inspectional Observations, was issued during this inspection, indicating a high level of compliance. However, two key discussion items were presented to management. First, the need to update work order forms for the stability chamber to include a verification step to ensure the motor is reactivated after maintenance. This recommendation arose after a maintenance event where the motor was unintentionally left off, causing a temperature fluctuation within acceptable limits. Second, management was advised to evaluate the necessity of backup power for critical equipment, such as stability chambers and laboratory/raw material refrigerators, to safeguard against power disruptions. Management agreed to update the stability chamber work order form and committed to evaluating the backup power recommendation. Previous inspectional findings from 2013, concerning stability studies and annual compendial testing, were verified as corrected. The firm demonstrated cooperation throughout the inspection.