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U.S. Department of Health and Human Services

Science & Research

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Volume III - 3.7 Consumer Complaint Letters

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Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-03

VERSION NO.:1.9

Section 3 – Recording of Results – Analyst Worksheet

EFFECTIVE DATE:
03-25-04
REVISED: 01-29-13

A complainant is to be informed of FDA's findings when a sample is examined. When the examination is completed (or if no examination is made), an inquiry is made to determine if the consumer wishes the sample returned.

There may be rare occasions when an intact complaint sample serves as the basis for legal actions. On these occasions, the compliance branch is consulted before an offer to return the remaining sample is made.

A letter is sent to the complainant advising the individual of the general nature of the findings. When additional interpretation is indicated, an explanation of the findings is included. If an examination has not been made, the complainant is informed and given the reason(s). Do not offer to return the sample if it is needed for FDA regulatory purposes or if it has been purchased from the complainant.

Sufficient copies of the consumer complaint letter must be provided for distribution to:

  • the complainant (original); and
  • the home district and collecting district, if different from the examining district (1 copy each); and
  • the analyzing laboratory (1 copy).

The letter to the complainant is sent by certified mail, return receipt requested, to establish a clear record of the transaction. If the complainant requests the sample, the sample is returned and an appropriate record maintained. Complaint samples are held for at least thirty days from the time the letter is sent. If sample return is not requested by the complainant during this period, the sample may be destroyed.

Cosmetic injury complaint reports will be handled by the Center for Food Safety and Applied Nutrition.