FDA Form 483, Inspectional Observations: Deadline for Response


FDA 483 deadline

2 Week Deadline to Respond to FDA 483

The Form FDA 483, Inspectional Observations, is the first step on the road to most FDA enforcement actions. The form can be issued by an FDA investigator at the conclusion of an inspection. It lists what the investigator feels are “clear and significant” violations of the FDA regulations. There is no requirement to respond to a 483 but it is highly recommended. Now, there is a 15 business day deadline for a company to respond if it is going to be considered when FDA compliance officials decide to write a Warning Letter. Read more about the Form FDA 483 on the page at the top of the Blog. Read more about FDA’s new deadline on the Blogroll at: “PharmTech Talk,” the blog of Pharmaceutical Technology, one of the publications in the Life Sciences group of Advanstar Communications. You can also scroll down to an interesting post on “Sharfstein Addresses Industry,” the PDA, that outlines his public health approach for FDA. This is an interesting blog well worth keeping tabs on. Also from Advanstar is the new blog for Applied Clinical Trials which I am also adding to the Blogroll.

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