FDA 510(k) Consulting, FDA 510(k) Consultant

483 Observations & Warning Letter Responses

Is the 483 observation serious?

Yes, it’s serious because the inadequacy of your response can lead to further FDA actions including issue of a warning letter. It’s important to respond to FDA carefully to avoid escalation of the review and further FDA action.

Received 483 Observations after FDA inspection, are you responding to them correctly?

You and your Company’s response to 483 Observations, Warning Letter and Recalls are critical to its survival in the present FDA regulation environment. The company’s response to FDA should be timely and comprehensive. Our FDA Consultant has successfully assisted many companies in their response to 483 Observations to FDA’s satisfaction.

Is it important to respond to FDA in 15 working days?

Most of the responses to FDA must be sent within 15 days.It’s critical to take utmost care when addressing the 483 observations. The FDA is looking for a response where appropriate actions are required and taken to remedy the observation. Your response must be appropriate, timely and comprehensive. The FDA wants to review the response where a non-conformance is opened, investigated to determine that the root cause of the observation and if warranted what corrective and preventive actions would be taken to correct the FDA’s observation.

Warning Letter Response

A Warning Letter has a profound impact on you, legal and regulatory implications on your business and it’s reputation. A Warning Letter is in effect a continuation of the communication between your company and the FDA concerning your 483 response. This warning letter will explain what has been accepted from your 483 response and what observation(s) were not appropriately addressed. The response to a Warning Letter, like a 483 response, should be complete,timely and comprehensive and must address every aspect of the Quality System impacted by the corrective action taken by your company.

Our FDA Consultants got the experience in responding to observations for Class I, II and III medical devices and has been successful in preventing a Warning Letter being issued as a result of an inadequate response. Please contact us if you have received a 483 Observation or Warning Letter from the FDA.