Other Laboratory Operations
Food and Drug Administration
- 2.7.1 Returning Samples to the Sample Custodian
- 2.7.2 Returning Samples to Storage Areas not controlled by the Sample Custodian
The laboratory reserve sample is kept until all legal or other action requiring the sample is closed. The reserve sample consists of the remaining FDA portion, and, if applicable, exhibits and the 702(b) claimant's portion.
Upon completion of the analysis, the Analyst returns any remaining sample reserve to the Sample Custodian for storage, unless the reserve needs storage conditions not under the control of the Sample Custodian. (e.g. storage in the laboratory).
For those samples returned to the Sample Custodian, the sample custodian and the analyst document the transfer of the sample in FACTS or LIMS.
The Sample Custodian verifies that the physical sample received matches that described in the FACTS or LIMS “Sample Transfer” record. Any discrepancies (e.g. quantity, unit) between the physical sample and the sample description in the “Sample Transfer” record are immediately reported to the analyst. Discrepancies are reconciled and, if needed, the FACTS or LIMS record is corrected. The Sample Custodian updates the sample storage location in the FACTS or LIMS “Sample Transfer” record.
Special storage may call for all or a portion of the sample or exhibits to be stored in areas not controlled by the Sample Custodian (e.g. the laboratory). If the reserve sample is not returned to the Sample Custodian, the following documentation is recorded on the Analyst Worksheet or electronic form, Block 11, Reserve Sample:
- location and environmental conditions where the reserve is stored;
- an explanation why the sample was not returned to the Sample Custodian for storage; and,
- amount of sample stored.