The FDA may examine your registered facility for various reasons, including a normal examination, a survey, or in response to a reported concern. An FDA investigator will check into the quality of the product and the manufacturing process and review specific documents and collect samples. The investigator will discuss any significant findings and concerns with your firm’s management after the FDA inspection and will leave a written report with your management of any conditions or practices that, in the investigator’s opinion, indicate objectionable conditions or practices.
Because the FDA representative will not generally propose particular corrective actions, your firm’s management can utilise this “Inspectional Observations” list, also known as an FDA Form 483, as a reference for corrective action.
The FDA Form 483 is not the conclusion by the agency that a situation violates the FD&C Act or any of its regulations. The FDA Form 483, an Establishment Inspection Report, all proof or paperwork gathered on-site, and any answers made by the firm are all taken into account. The Agency examines all of this information before deciding what additional action is necessary to safeguard public health.
FDA Inspection Guides