Field Reporting RequirementsAll 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 raising the
possibility of one or more violations of the Federal Food Drug & 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. If an FDA-483 is issued, a copy
will be faxed to the Center contact identified in the assignment.
If 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.
If samples are collected for analysis, the analyzing laboratory will submit
copies of the Collection Report and the Analytical Work sheets to the District Office and
the assigning Center.