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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Compliance Program Guidance Manual

Food and Drug Administration
Compliance Program Guidance Manual

PROGRAM

7348.808

 Chapter 48
Bioresearch Monitoring
Date of Issuance: February  21, 2001
Guidance For FDA Staff

This document is intended to provide guidance. It represents the Agency’s 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

Good Laboratory Practice
(Nonclinical Laboratories)

Implementation Date

February 21, 2001

Completion Date

Continuing

Data Reporting
PRODUCT CODES PRODUCT/ASSIGNMENT CODES

51Z OR 52Z

04808 Chemical Contaminants (EPA)

45Z, 46Z

09808 Food Additives

57Z, 99Z 

41808 Biologics (Therapeutics)
42808 Biologics (Blood)
45808 Biologics (Vaccines)

60Z, 61Z

48808 Human Drugs

68Z, 69Z

68808 Animal Drugs

73Z, 74Z
94Z OR 95Z

83808 Medical and Radiological Devices


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 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.

Hypertext updated April 3, 2001 tmc