> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Central Admixture Pharmacy FDA-483
- URL: https://www.fdaweb.com/central-admixture-pharmacy-fda-483/
- Published: 2022-06-16T12:00:00.000Z
- Updated: 2026-09-14T17:49:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152089

FDA has released the FDA-483 issued following a 2/14-2/25 inspection at Central Admixture Pharmacy Services, a Phoenix, AZ, outsourcing facility. The six inspection observations were: 

- procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process;
- aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions;
- laboratory records do not include a record of all calculations performed in connection with the test;
- appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel;
- equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality, or purity of the drug product; and
- failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.