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CAPS operates as the nation's largest network of outsourcing admixture pharmacies, providing commercial compounding services through FDA-registered 503B facilities and state-licensed 503A pharmacies. The company has faced significant regulatory challenges in 2024, receiving multiple FDA warning letters for serious Current Good Manufacturing Practice (CGMP) violations at facilities including Phoenix, Allentown, and San Diego. The Phoenix facility's March 2024 warning letter cited issues such as visibly dirty production areas, inadequate response to microbial contamination in aseptic processing areas, and failures in quality control oversight. These were noted as repeat violations across multiple sites, indicating inadequate management oversight and control over manufacturing operations.
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