All establishment inspection reports (EIRs), complete with attachments, exhibits, and any post-inspectional correspondence are to be submitted promptly to the assigning Center. If an EIR contains serious findings that raise the possibility of one or more violations of the Federal Food Drug and Cosmetic Act (FFDCA) or other Federal statutes, a copy of the EIR should be forwarded to the District Compliance Branch at the time it is sent to the Center. When an FDA 483 is issued, a copy will be faxed to the Center contact identified in the assignment.

When the District becomes aware of any significant adverse inspectional, analytical, or other information which may affect the agency's new product approval decisions with respect to a firm, the District should immediately notify the responsible Center program office via electronic mail, fax, or by phone.