Analysis of FDA observations on non-compliance in pharmaceutical production

FDA 483s are forms completed by FDA inspectors alerting companies of areas to improve, or correct, to remain compliant. This white paper explains the importance of FDA 483s in the regulation of pharmaceutical companies and FDA-regulated products.

What are the consequences of non-compliance in drug production and QC, and how must a company respond to a 483 or the need for a product recall? In this white paper, explore some recent and ongoing cases where 483s and product recalls have been issued. Plus, learn about the importance of monitoring and maintaining the correct level of water purity across pharmaceutical processes.