Are manufacturers, importers, distributors, or retailers subject to inspection by FDA?
A s devices, imported decorative contact lenses that do not comply with applicable premarket device requirements are subject to detention without physical examination under the procedures described in FDA’s Import Alert #89-08, “Detention without Physical Examination of Devices without Approved PMA’s or IDE’s and Other Devices not Equivalent or no 510(k)” (see also section 801 of the act, 21 U.S.C. 381). The import alert instructs FDA personnel and officials of the United States Customs Service to detain automatically all devices presented at the United States ports of entry that are in violation of federal law. Import Alert #89-08, can be accessed on the Internet.
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- Are manufacturers, importers, distributors, or retailers subject to inspection by FDA?
