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# Apollo Care FDA-483
- URL: https://www.fdaweb.com/apollo-care-fda-483/
- Published: 2022-05-17T12:00:00.000Z
- Updated: 2026-09-14T17:44:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151832

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.