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| Other Laboratory Operations Food and Drug Administration |
| DOCUMENT NO.: III-03 | VERSION NO.:1.5 | Section 3 – Recording of Results – Analyst Worksheet | EFFECTIVE DATE: 03/25/2004 | REVISED: 08/11/2008 |
3.7 Consumer Complaint Letters
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.
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