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U.S. Department of Health and Human Services

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Volume IV - 14.3 FDA Laws and Regulations

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Orientation and Training

Food and Drug Administration

DOCUMENT NO.:
IV-14
VERSION NO.: 1.5

Section 14 - Complaints & Tampering

EFFECTIVE DATE:
10-01-03
REVISED: 02-14-13

A complaint serves as notification that a product in commercial distribution may be in violation of FDA laws and regulations. (1)

FDA is authorized to investigate reported tampering of FDA regulated products under the Federal Anti-Tampering Act, Title 18, USC, Section 1365. Note that the act not only makes tampering a crime but also identifies as criminal “whoever knowingly communicates false information about product tampering” and “whoever threatens.” The Office of Criminal Investigation (OCI) has the primary responsibility for all criminal investigations of tampering/threat incidents. (2, 3)