Apollo Care FDA-483

FDA has released the FDA-483 issued following an 8/16-9/8/21 inspection at Appollo Care, a Columbia, MO, outsourcing facility. The inspection observations were: 

•          failing to put in writing and fully follow the responsibilities and procedures applicable to the quality control unit;
•          failing to establish, write, and follow procedures designed to prevent objectionable microorganisms in drug products purporting to be sterile;
•          aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
•          aseptic processing areas are deficient in that the floors, walls, ceilings, and work surfaces are not smooth and/or hard surfaces and are not easily cleanable; and
•          procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of a specific [redacted] process.