Articles — 483

The U.S. Food and Drug Administration (FDA) is responsible for protecting public health by ensuring the safety, efficacy, and security of pharmaceuticals, biologics, and much more. It is one of the leading regulatory and compliance agencies that a compounding pharmacy will work alongside while developing products. The FDA is responsible for routine inspections, which many manufacturers know all too well! But, three little numbers - 483 - can come from the inspections, and they mean serious business. But there are two different types of terms associated with these numbers: "Observations" and "Warning Letters." Today, we'll look at the difference between...