STAT+: FDA inspection underscores problem at major U.S. compounder behind hospital drug recalls
The FDA found several issues that raised the possibility of contamination at a facility run by a major drug compounder that makes medicines used in hospitals.
One of the largest compound pharmacy operations in the U.S. recently recalled a slew of injectable medicines used by hospitals over concerns about possible side effects and a newly released regulatory report underscores the extent of the problem.
The Food and Drug Administration found several issues that raised the possibility of contamination during an inspection of an Allentown, Pa., facility run by Central Admixture Pharmacy Services. These issues included inadequate environmental monitoring and follow-up investigations, according to an inspection report posted online this week.
For example, there were 100 instances between November 2022 and March 2023 in which the company found what the FDA called a “significant number” of bacteria, yeast, mold, and other spore-forming organisms. Yet the compounder failed to investigate the causes or take adequate corrective or preventive actions to mitigate the risk of formation.
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