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Volume III - 3.6 Abbreviated Recording and Reporting of Findings for Surveillance Samples

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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

FMD 77 describes procedures to be used by laboratory analysts for recording sample information and analytical findings for surveillance samples. This procedure simplifies data recording for surveillance samples collected for informational purposes only and which by nature are not used for compliance actions. It is intended to promote more efficient use of laboratory resources, and not to be used for or in support of regulatory actions to include follow-ups to out-of-limit surveillance samples.

 

ORA-LAB.5.10, Section 6. H. 2. describes additional information on abbreviated reporting.