Q: When is an FDA form 483 issued?
A: An FDA Form 483 is issued for the administration of the company at the end of an inspection when an investigator (s) has observed a condition that in their judgment may constitute violations of the Food and D–g Law (FD&C) and laws. related. FDA researchers are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and meaningful. The observations are made when, in the opinion of the researcher, the conditions or practices observed indicate that any food, d–g, device or cosmetic has been adulterated or is being prepared, packed or retained in conditions that may adulterate or harm health.
Q: What is the purpose of an FDA Form 483?
A: FDA Form 483 notifies the company administration of objectionable conditions. At the conclusion of an inspection, FDA Form 483 is filed and discussed with the company's senior management. Companies are encouraged to respond in writing to FDA Form 483 with their corrective action plan and then implement that corrective action plan quickly.
Q: Is the FDA Form 483 intended to be a complete list of all possible deviations from the law and regulation?
A: No, it is not. The FDA Form 483 is a report that does not include observations of questionable or unknown importance at the time of inspection. There may be other objectionable conditions that exist in the company that are not cited in FDA Form 483. FDA investigators are instructed to write down only what they saw during the course of the inspection. Companies are responsible for taking corrective measures to address the objectionable conditions cited and the related unquoted objectionable conditions that may exist.
Q: How is FDA Form 483 shared with the company?
A: FDA Forms 483 are discussed with the management of a company at the end of the inspection. Each observation is read and discussed so that there is a complete understanding of what the observations are and what they mean.
Q: What are the implications of the FDA Form 483 for the agency's application and what happens next?
A: FDA Form 483 does not constitute a final determination by the Agency as to whether any condition violates the FD&C Act or any of its relevant regulations. FDA Form 483 is considered, along with a written report called the Site Inspection Report, all evidence or documentation collected on the site, and any responses made by the company. The Agency considers all this information and then determines what additional action, if applicable, is appropriate to protect public health.