Consultants specialising in regulatory affairs



483 Observations and Responses


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 misstep at any point can result in product seizure, recalls, or company closure. A company's response must be timely, and comprehensive.

483 Observations after your factory audit by the FDA cannot be approached lightly. The comprehensiveness of your response is the only thing that is standing between your company and a Warning Letter.

Most responses must be returned to the FDA in 15 working days, so utmost haste when addressing 483 observations is critical.

Most companies respond to 483 in a conversational manner by explaining or justifying what happened. The FDA is looking for neither, but wants a response where appropriate actions are taken to remedy the observation. 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.

If a CAPA is opened the respondent must detail each step to be taken to correct the observation based on the root cause analysis. Record each step to be taken in the corrective action and what steps will be taken to verify that the corrective action has been taken and no unintended consequences have occurred as a result of the corrective action. Additionally, the company should provide information on management follow-up to the observation.

Your response must be comprehensive and address every aspect of the Quality System impacted by the correction. We are 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.