The FDA inspection process begins with the issuance of FDA Form 482. This form provides notice of an impending site inspection that will take place at a particular plant or other facility.

The FDA uses the Form 482, establishment inspection report and other relevant information to determine action against NECC. The inspection report has not been completed. Release of the Form 483 ...

When FDA inspectors show up to conduct on-site audits, they will have an FDA Form 482 (Notice of Inspection). This Form states the statutory authority of the FDA to conduct the audit and explains ...

FDA has held fast to its view that an inspection—which begins with the presentation of FDA credentials and FDA Form-482 and often ends with an FDA Form 483 listing concerning observations—is on-site ...

The FDA findings were part of a pattern of deficiencies noted at the plant following inspections this year, as well as in 2019 and 2021. The findings in the preliminary report, called a form 483 ...