C. Foreign particles found in [redacted] API [redacted]
Your investigation into foreign particles found in [redacted] batch [redacted] identified:
- green fibers consistent with scouring pads
- red flakes consistent with paint in the manufacturing plant
- black particulates consistent with glass particles
You concluded that these were “acceptable intrinsic” contaminates.Scouring pads! That's a new one.
Your response is inadequate. It failed to include a root-cause evaluation of glass particles and the foreign materials found in these drugs. You also failed to evaluate the impact of the contaminants on all other drugs manufactured with the same equipment in the same facility.
In response to this letter, provide a risk assessment for the (b)(4) manufacturing process and other drugs produced with the same equipment. Include an evaluation of the physical condition of your facility and of your cleaning and preventive maintenance procedures for your manufacturing equipment.