FDA import alert
Import Alert 66-76
Detention Without Physical Examination of Drugs or Active Pharmaceutical Ingredients From Facilities That Have Not Submitted Self-Identifying Information or Paid Facility or Program Fees Required Under GDUFA
3
Red-list entries
0
Green-list entries
2
Countries
2016-07-13
Last change seen
What being on this list means
Firms on an import alert's Red List are subject to Detention Without Physical Examination (DWPE): FDA can detain their shipments at the border automatically, without sampling or inspecting them. The burden shifts to the importer to prove — typically with private laboratory analysis, shipment by shipment — that the goods are not violative. Removal from the list requires evidence that the underlying problem is resolved, usually including a track record of consecutive clean shipments and a petition to FDA. How removal works →
A Green List on a countrywide alert works the other way: it names the firms FDA has excluded from detention because they demonstrated compliance.
Red-list entries by country
Firms on this red list
Showing 3 of 3 entries — search a specific firm on the free checker.
Jiangsu ZW Pharmaceuticals Co. Ltd.
07/13/2016
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Wuxi Kaili Pharmaceutical Company LTD.
07/13/2016
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Sharon Bio-Medicine Limited
07/13/2016
India · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Does this alert touch your supply chain?
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