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| Other Laboratory Operations Food and Drug Administration |
| DOCUMENT NO.: III-07 | VERSION NO.:1.3 | Section 7 – Private Laboratory Guidance | EFFECTIVE DATE: 10/01/2003 | REVISED: 06/27/2008 |
7.6 Consultations
Private laboratories often request FDA guidance and advice. The most frequently
asked questions are about the methods to be used. FDA should be helpful in
providing this information, although it is ultimately the responsibility of
the importer or broker and the private laboratory to provide FDA with the documentation
and assurance needed. As long as information from standard sources is provided,
such as a referral to the AOAC Official Methods of Analysis, it need not be
documented by the FDA employee. If the advice is to an alternate source, or
involves other issues, then it should be documented in a memo of the conversation.
A copy of the memo should be given to the compliance officer and a copy kept
with the file on the private laboratory.
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