FDA 483 - Spencer Specialty Products Inc - April 04, 2025

Spencer Specialty Products Inc, a drug manufacturer in Boise, ID, received four repeat observations during an FDA inspection. The firm demonstrated significant deficiencies in its quality system, including a non-existent quality control unit, inadequate raw material testing, and a lack of a stability testing program. Additionally, the facility failed to maintain adequate controls to prevent contamination and mix-ups in its production area.