How serious is a 483 Observation?

It is serious since the inadequacy of your response can lead to further FDA actions including a Warning Letter. The object of careful response is to avoid that escalation of review.

I have received 483 Observations after my FDA inspection, how do I know if I am answering them correctly?

A company’s handling of responses to 483 Observations, Warning Letter and Recalls are critical to a company’s survival in the present FDA regulation climate. A company’s response must be timely, and comprehensive. Smith Associates has successfully assisted many companies in their responses to 483 observations to the FDA’s satisfaction.

I am not sure I can respond in 15 working days. Is this important?

Most responses must be returned to the FDA in 15 working days, so utmost haste when addressing 483 observations is critical. The FDA is looking for a response where appropriate actions are taken to remedy the observation. Your response must be timely but comprehensive. They want to review a response where a non –conformance is opened, the observation is investigated to determine the root cause of the observation and if warranted what corrective and preventive actions will be taken to correct the observation. Smith Associates is experienced in the responses in Class I, II and III products and has been highly successful in preventing a Warning Letter being issued as a result of an inadequate response.

Warning Letter Response

A Warning Letter has a profound impact on your business and business reputation. A Warning Letter is, in effect, just a continuation of the communication between the FDA and the company concerning your 483 response.

The Warning Letter will explain what has been accepted from your 483 response and what observation(s) were not appropriately addressed. Like the 483 response, a Warning Letter response must be comprehensive and address every aspect of the Quality System impacted by the correction.