This article discusses the FDA's role in regulating compounding pharmacies, focusing on the implications of receiving FDA Form 483 observations and warning letters during inspections. It explains the key differences between observations and warning letters, emphasizing the seriousness of the latter, which can lead to business-threatening regulatory violations. The importance of compliance and the role of companies like MediZap in assisting compounding pharmacies in maintaining compliance and preparing for inspections are highlighted.
MediZap is the only contract terminal sterilizer by E-Beam | X-Ray irradiation built for compounders. Our 4 Pillar Service includes Advanced Sterilization, Packaging Solutions, Compliance, and Exclusive Partnerships. We offer 48-hour processing, dedicated capacity, group pricing, and a compounding center of excellence. USP 797 and cGMP guidelines start with terminal sterilization, and our technology is the most advanced solution, ensuring low-risk 10-6 SAL and delivers the safest drug products to hospitals, practitioners, and patients.
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Infusion Pharmacy Resources IV/Infusion Resources/USP <797> Resources USP <800> Compliance
