FDA 483s and Non-Compliance in Pharma

The United States Food and Drug Administration (FDA) has the authority to inspect pharmaceutical companies that manufacture FDA-regulated products at any time, and write down their observations on Form FDA 483, commonly abbreviated to “483”. Form 483s are very important to FDA- regulated companies, regardless of how many, if any, they have received. A single 483 tells a company exactly which areas to improve - or to correct - to remain compliant (and therefore operational). Downplaying the 483 content and, more importantly, not responding seriously and completely to the observations can have costly consequences. Download this white paper to learn more about FDA 483’s, drug production, compliance and QC.

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