Evidence Required for Detention (pg. 26)
Every detention must be based upon evidence of a violation of the law(s) enforced by
FDA. This does not mean that comprehensive examinations are required as a condition
for detention, or that detention cannot be based upon very brief examinations if these are
sufficient to furnish evidence creating the appearance of a violation, or a violation.
Furthermore, it is not essential that a detention invariably be based upon examination of
a sample, as Section 801(a) of the FFDCA provides for refusal of admission if "it appears
from the examination of such samples or otherwise" that the article is violative. However,
in those cases in which detention is made without examination, there should be
substantial evidence of a documentary type, (i.e., a violation in
a previous shipment of the
entered product from the same firm-see RPM subchapter 9-8 "Detention without Physical
Examination" for additional procedures) to warrant a charge of violation.
FDA can destroy drugs refused admission, without the opportunity for export, that are
valued at $2500 or less and are adulterated, misbranded, or unapproved in violation of
Section 505 of the FFDCA. The evidence supporting this determination must be collected
and documented in OASIS by the Investigations Branch for review and evaluation by the
Compliance Branch.