FDA 483 - Central Admixture Pharmacy Services, Inc. - August 18, 2025

An FDA inspection conducted between August 18, 2025, and September 5, 2025, at Central Admixture Pharmacy Services, Inc., an Outsourcing Facility, identified significant violations related to quality control and product release. The primary observation highlighted a systemic failure to thoroughly review unexplained discrepancies and batch components that did not meet specifications, a critical aspect of good manufacturing practices.The company exhibited recurring quality issues from July 2023 to August 2025, involving sterile drug products like IV bags and syringes. Defects frequently observed included particulate matter, delamination, leaky ports, and damaged labels, leading to high rejection rates. For instance, from April 2024 to August 2025, over 20% of non-conformances were due to particulate matter, and a recent three-month period saw 30% of manufactured batches rejected for various defects, resulting in final yields as low as 6% for some released products.The firm"s Quality Unit failed to enforce yield limits, often releasing low-yield batches without sufficient scientific justification or robust root cause analysis. Investigations into these recurring problems lacked effective corrective and preventive actions. Furthermore, the company relied on visual inspection methods without employing more accurate analytical techniques to confirm the absence of subtle or sub-visible defects in released products. To address these findings, Central Admixture Pharmacy Services, Inc. must implement comprehensive investigations, robust root cause analysis, and scientifically sound corrective actions to ensure consistent product quality and compliance with regulatory standards for outsourcing facilities.