FDA 483 - Central Admixture Pharmacy Services, Inc. - June 11, 2014

During an inspection from June 4-11, 2014, Central Admixture Pharmacy Services, Inc. of Allentown, PA, an outsourcing facility, received an FDA Form 483 detailing significant deficiencies in their manufacturing processes for sterile drug products. The main issues revolved around the lack of established and followed procedures to prevent microbiological contamination. Specific violations included turbulent airflow in critical areas, poor aseptic techniques by operators who blocked HEPA filter air, and inadequate media fill simulations that did not represent actual production conditions. Personnel gowning practices were found to be deficient, leading to exposed skin and contamination risks. The facility’s buildings were not maintained in a clean and sanitary condition, with improper storage of cleaning supplies and items obstructing laminar airflow in sterile environments. Furthermore, control systems for environmental monitoring were inadequate, with illegible records and incomplete investigations into contamination alerts. The flow of components was compromised, with sterile materials exposed to unclassified warehouse conditions. The company lacked a written stability testing program for their products, and some drug product labels omitted the required “This is a compounded drug” statement. These observations indicate a broad failure to adhere to Good Manufacturing Practices, requiring comprehensive corrective actions to ensure drug product quality and patient safety.