Keeping up with the FDA

Posted on December 11, 2012

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 practical policy changes the FDA makes, with the goal of constant industry improvement. These changes often take the form of industry guidances, which reflect the FDA's current mindset about various aspects of certain industries. Some guidances receive large amounts of attention in the media and are difficult to overlook. Others however, are less publicized and are missed by some companies, resulting in negative findings during an FDA site visit.

The FDA does make serious efforts to ensure that regulatory information is readily available to the public. Fda.gov contains a vast wealth of literature, including industry...

Warning letters, what they are, how we can help

Posted on October 09, 2012

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 serious violations, a Warning Letter is generally issued by the FDA following an extensive review of site inspection results, usually within 30 days of the inspection close out. The purpose of a Warning Letter is to notify companies that they are operating in violation of The Act, and that they are expected to remedy all outstanding issues in order to become compliant. The significance of a Warning Letter versus a 483 is that a Warning Letter is an official statement by the FDA confirming that a company is operating out of compliance, whereas a 483 is an inspector’s (highly influential) opinion on the matter, but is not an official Agency...

FDA 483: Does your business contain critical errors?

Posted on August 22, 2012

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, and warning letters. Fortunately, the process followed by the FDA is intended to allow most companies operating out of compliance to remediate their practices and continue operation in an acceptable manner. Although the remediation process tends to be hectic and unpleasant, it can actually be beneficial for a company because if done correctly, the remediation will result in higher quality business practices.

At the conclusion of an FDA site visit, the inspectors will issue an FDA Form 483 if there are observations. A 483 lists detailed observations of any issues the inspectors consider...