Keeping up with the FDA

Quite a few companies in FDA regulated industries are experiencing “Dynamic Shock.” After handling their operations and quality assurance in the same manner for years, they are suddenly faced with severe findings on a 483, or are even issued a warning letter. Dynamic Shock stems from the constantly shifting nature of the industry and the

Posted in FDA

Warning Letters: What they are, How we can help

As discussed in our previous post, “FDA 483: your company contains critical errors,” a company whose operations are not compliant with the regulations set out by the Federal Food, Drug, and Cosmetic Act and related acts (The Act) is likely to face serious consequences from the FDA. Although there are exceptions in the case of

FDA 483: Does your business contain critical errors?

In the aftermath of an FDA site inspection resulting in unsatisfactory findings, the company in question faces a difficult situation that must be addressed quickly to avoid serious consequences. If not properly addressed, negative observations made during an FDA visit can ultimately result in suspended operations, bad press, scrupulous monitoring of operations, recall of products,