483
Spencer Specialty Products IncSpencer Specialty Products Inc – FDA 483, Apr 4, 2025
Record Details
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.
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- Seattle District Office
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ID · 3e419322-a846-4065-9374-b2f51d360586
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