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The agency noted that its investigators found its manufacturing facility "in a state of disrepair, poorly cleaned, and poorly maintained." FDA listed several examples of its observations, including grime and discolored lubricant on manufacturing equipment, flies and standing water in the manufacturing area, mold in the air conditioning vents, and a cockroach in the packaging area

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Practices should query payer portals before each injection cycle rather than assuming continued coverage based on initial authorization