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.
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