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U.S. Department of Health and Human Services

Science & Research

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Volume III - 7.6 Consultations

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Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-07

VERSION NO.:1.4

Section 7 – Private Laboratory Guidance

EFFECTIVE DATE: 10/01/2003REVISED: 01/30/13

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.