The FDA recently completed an inspection of your company and one or more FDA Form 483 inspections have been registered by the inspection team. How and when your company will respond to these observations is an important decision.
You can browse the web to know about what is an FDA inspection? This article provides guidance on what to do to minimize or avoid further enforcement actions.
When the FDA initiates an inspection, Form 482 (Inspection Notification) and contact information are provided if a response 483 is issued. 482 defines inspection agency and sets expectations for inspectors and companies.
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Form 483 includes comments from FDA representatives during the inspection. This comment is not a final compliance decision by the agency. 483 officially notifies the organization's top management of any undesirable conditions or practices related to federal Food, Drug and Cosmetics (FD&C) violations that occur during an observed inspection.
If the examination does not produce clear conditions or practices, the 483 will not be excluded. However, if an FDA representative meets an undesirable condition, one or more 483 will be excluded during the closing meeting.
If the agency issues one or more 483s at the end of the examination, it is always better to select "correction appointments" and were not "considered" in response to 483 observations.
Depending on the nature of the offense, the FDA may permit companies to take immediate and voluntary action to remedy violations before they can take enforcement action. However, the FDA generally has no obligation to warn individuals or companies of violations before taking further enforcement action, as described below.