SHIN CHAN SONG ABOUT HIS PENIS IN THE BATHTUB REGISTRATION
Divisions will refer such applications related to this alert to ***CDRH Imports and Registration & Listing Team,*** for concurrence. DIO will coordinate a review of all recommendations for addition to detention without physical examination with ***CDRH Imports and Registration & Listing Team.*** Release of devices subject to detention without physical examination under this import alert: In order to secure release of an individual shipment subject to detention without physical examination under this import alert, the owner, consignee and/or another responsible party to the shipment may submit to the FDA a written application (Form FDA 766) requesting authorization to bring a device that has been detained without physical examination per this import alert into compliance by relabeling or other action (reconditioning). A recommendation for addition to detention without physical examination, including analytical worksheets (if the product was analyzed), labeling, package inserts, user manuals, photographic evidence, website information, entry documents, etc., should be forwarded to the Division of Import Operations (DIO).
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Divisions may detain, without physical examination, the indicated devices from the firms identified on the Red List of this import alert.