You’ve received one of the dreaded FDA Warning Letters. The last thing you want is to delay the launch of your company’s [...] Read More
GxP-CC is delighted to announce the addition of Dr. Simone Peschl as the company’s new Operations [...] Read More
The manufacture and sale of medical devices, be they intravenous catheters or operating tables, is a highly complex undertaking requiring a deft balancing of FDA regulatory concerns with ambitious output [...] Read More
Under the Federal Food, Drug and Cosmetic Act, SEC. 704 (21 USC §374) “Factory Inspection” the United States Food and Drug Administration (FDA) is authorized to perform inspections of US and foreign facilities. Form FDA 483 (Inspection Observations) is used by FDA to document concerns discovered during inspections.
The 483 states that it “lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional [...] Read More
Before selling their products, firms have to ensure that they adhere to US and European government regulations. This is a job in and of itself; staff at all levels must maintain extensive conversance with a huge body of rules devised by the Food and Drug Administration (FDA) and other regulatory bodies.
For specialized companies trying to stay legal, such a herculean task is practically impossible without outside assistance, when one considers the restrictions that [...] Read More