Skip page top navigationFDA Logo--links to FDA home page Logo of and Link to start page of Office of Regulatory Affairs, U.S. Food and Drug Administration U.S. Food and Drug Administration Office of Regulatory Affairs HHS Logo and link to Department of Health and Human Services website

FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search

7348.811 CHAPTER 48 - BIORESEARCH MONITORING

CLINICAL INVESTIGATORS OCTOBER 1, 1997 SEPTEMBER 30, 2000

45z, 46z

57z, 99z

60z, 61z

68z, 69z

73z, 74z, 94z, 95z

09811 Food Additives

41811 Biologics

(Therapeutics)

42811 Biologics (Blood)

45811 Biologics (Vaccines)

48811 Human Drugs

68811 Veterinary Drugs

83811 Medical Devices

FIELD REPORTING REQUIREMENTS

All establishment inspection reports (EIR's), complete with attachments, exhibits, and any related correspondence are to be submitted in a timely fashion to the assigning Center.

When a Form FDA 483 is issued, a copy should be faxed to the Center contact identified in the assignment.

If an EIR contains serious findings raising the possibility of one or more violations of the *Food, Drug, and Cosmetic (FD&C)* Act or other federal statues, a copy of the EIR should be forwarded to the District Compliance Branch at the time it is sent to the Center.

*Current Change*

Hypertext updated August 20,1998 by djv