A 483 observation is a notification of inspectional observations issued by the U.S. Food and Drug Administration (FDA) to a regulated facility after an inspection. This observation is named after the FDA form number 483, which is used to document and communicate the inspectional observations made by the FDA during the inspection of a regulated facility.
The FDA typically issues a Form 483 after an inspection when it has observed conditions or practices that may violate the Food, Drug, and Cosmetic Act or related laws and regulations. The observations listed on the 483 are not necessarily a final determination by the FDA that a violation has occurred, but rather they are preliminary findings that require further investigation and evaluation.
The facility is typically given a specific period of time to respond to the observations listed on the 483, and to provide the FDA with a plan of action to address the issues raised. The FDA may then conduct a follow-up inspection to verify that the corrective actions have been implemented.
What to do if you receive an FDA 483 observation?
If you receive an FDA Form 483 after an inspection, it is important to take it seriously and respond promptly and appropriately. Here are some steps you can take:
- Read the Form 483 carefully: Carefully review each observation listed on the Form 483 and make sure you understand the issues raised by the FDA.
- Develop a response plan: Develop a plan to address each observation listed on the Form 483. This plan should include specific steps you will take to correct the deficiencies identified by the FDA.
- Respond in a timely manner: You will have a specific time frame to respond to the observations listed on the Form 483. Make sure you respond within the given time frame and provide the FDA with a complete and thorough response.
- Implement corrective actions: Once you have developed a response plan, implement the necessary corrective actions to address the deficiencies identified by the FDA.
- Follow up with the FDA: The FDA may conduct a follow-up inspection to verify that the corrective actions have been implemented. Be prepared for this possibility and ensure that your corrective actions have been fully implemented before the follow-up inspection.
It is important to take the observations listed on an FDA Form 483 seriously and take appropriate steps to address any deficiencies identified by the FDA. Failure to do so could result in further regulatory action by the FDA, which could have serious consequences for your business.
However, please note that the issuance of a Form 483 does not necessarily mean that a company is in violation of the law. It is important to read the observations carefully and understand the context of the inspection before drawing any conclusions.