Top 10 Reasons for FDA 483
- An FDA Form 483 is issued to a company’s management at the conclusion of an inspection when an investigator(s) has observed any conditions that, in their judgment, may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
- FDA’s Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement.
- FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant.
- Observations are made when, in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.
- The FDA Form 483 notifies the company’s management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management.
- Do you have to respond? Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan in the stated time frame.
- The FDA Form 483 is a report which does notinclude observations of questionable or unknown significance at the time of the inspection. There may be other objectionable conditions that exist at the firm that are not cited on the FDA Form 483.
- FDA investigators are instructed to note only what they saw during the course of the inspection. Companies are responsible to take corrective action to address the cited objectionable conditions and any related non-cited objectionable conditions that might exist.
- The FDA Form 483 does not constitute a final Agency determination of whether any condition is in violation of the FD&C Act or any of its relevant regulations. The FDA Form 483 is considered, along with a written report called an Establishment Inspection Report, all evidence or documentation collected on-site, and any responses made by the company. The Agency considers all of this information and then determines what further action, if any, is appropriate to protect public health.