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U.S. Department of Health and Human Services

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Volume III - 7.7 Meetings

DFS Pyramid Logo

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

Meetings may be held between the private laboratory and the ORA laboratory and/or the home district. Sometimes, these are held at the request of the private laboratory. More commonly, they are held when FDA feels that they are needed to facilitate the resolution of unresolved problems involving the private laboratory. If there is a particular entry involved, the importer or broker should be notified and invited to such discussions. The ORA laboratory and district staff should provide the firms with clear explanations as to why the analytical results are not acceptable and with the criteria that is to be met for acceptance. The increase in understanding that frequently results and the ensuing discussion can often be helpful in resolving outstanding problems. At each of these meetings, a secretary (from FDA) should be designated. The secretary is responsible for preparing notes of the meeting, which should be provided to the home district and copied to the file.