The FDA may examine your registered facility for a variety of 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, as well as review specific documents and collect samples. The investigator will discuss any significant findings and concerns with your firm’s management at the conclusion of the inspection and will leave a written report with your management of any conditions or practises 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 list of “Inspectional Observations,” also known as an FDA Form 483, as a reference for corrective action.
The FDA Form 483 is not a final conclusion by the agency as to whether a situation is in violation of the FD&C Act or any of its regulations. The FDA Form 483, as well as 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, if any, additional action is necessary to safeguard public health.
FDA Inspection Guides