Ora Laboratory Manual - Fda Office Of Regulatory Affairs Page 13
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21The samples are returned to the Sample Custodians. Exceptions include the following
circumstances:
• analyst has received permission in advance from laboratory supervision to effect
immediate In-House Disposition of the sample (see 2.9 Disposition of Samples),
• entire sample has been consumed during analysis, and,
• reserve sample needs special environmental storage or handling conditions not
found in the sample storeroom.
The reserve sample consists of any remaining FDA portion and exhibits associated with
an Official Sample (e.g. Investigator/Inspector filth exhibits and Analyst filth analysis
plates), and the 702(b) claimant’s portion. Section 702(b) of the FD&C Act requires
‘…upon request, provide a part of such official sample for examination or analysis by
any person named on the label of the article, or the owner thereof, or his attorney or
agent….’ A domestic sample collected directly from a manufacturer may not be used in
its entirety, as an analyst is not authorized to use a 702(b) claimant’s portion.
Each portion of the reserve sample should remain in its original container, if possible,
and, if appropriate, officially sealed using FDA-415a. The sample is then returned to the
Sample Custodian for storage until the sample is dispositioned. If a seal is placed on the
reserve sample, the seal is quoted on the Analyst Worksheet, FDA 431, Reserve Sample.
2.6.1 Sealing the Reserve Samples
The reserve portion of samples is officially sealed using FDA-415a prior to being
returned to the Sample Custodian. The seal is affixed so that it actually seals the sample
package and the sample package cannot be opened without any evidence of tampering.
More than one seal may be needed. The original broken seal is not to be defaced or
hidden when resealing a sample. All seals must be visible to provide a continuity chain.
The Investigator’s seal on the sample, the Analyst’s information on the broken seal and
the Analyst’s seal(s) on the sample should all be visible should the sample be introduced
as a court exhibit
2.6.2 Documenting the Reserve Samples
For accountability purposes, a clear description of the reserve sample, including the
702(b) claimant’s portion (if present), is documented on the analyst worksheet. The
amount of reserve sample remaining is compatible with the amount received and the
amount used in the analysis; any discrepancies are explained on the analyst worksheet.
If no physical sample or exhibits remains:
ORA Lab Manual, Volume III, Section 2 – Chain of Custody-Sample Handling
Page 13 of 21
This document is uncontrolled when printed: 6/4/2014
For the most current and official copy, check the Internet at
http://
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