Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links

-

Inspections, Compliance, Enforcement, and Criminal Investigations

Share

-

Program 7348.810

Program 7348.810
CHAPTER 48 - BIORESEARCH MONITORING
SPONSORS, CONTRACT RESEARCH ORGANIZATIONS AND MONITORS
Date of Issuance: February 21, 2001
Guidance for FDA Staff

This document is intended to provide guidance. It represents the Agencys current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
Subject SPONSORS, CONTRACT RESEARCH ORGANIZATIONS AND MONITORS	Implementation Date February 21, 2001
	Completion Date Continuing
Data Reporting
Product Codes	Product/Assignment Codes
45Z, 46Z 57Z, 99Z 60Z, 61Z 68Z, 69Z 73Z, 74Z 94Z, 95Z	09810 Food Additives 41810 Therapeutics Products 42810 Blood and Blood Products 45810 Vaccines and Allergenic Products 48810 Human Drugs 68810 Veterinary Drugs 83810 Medical Devices and Radiological Health
Field Reporting Requirements 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.

-

-

-

-

-