57-15
Unlicensed Allergenic Products
4 firms from 3 countries are named on this alert. Their shipments may be detained at the port without physical examination. The oldest listing here dates to 10 September 2009, the newest to 14 May 2010.
- 4firms listed
- 3countries
- 30 January 2026alert last published
- Source on FDA →accessdata.fda.gov
Why FDA issued it
NOTE: The revision of this Import Alert, dated 08/27/2024, updates the title, the reason for alert section, the guidance section including removal from detention without physical examination under this import alert, agency contact information, product description section. Changes are bracketed by asterisks (***). FDA has determined that the firms listed below have been sending unlicensed allergenic products to the United States (U.S.). ***Foreign establishments having a U.S. license for the manufacture of allergenic products also manufacture unlicensed versions of allergenic products. Only allergenic products manufactured under the U.S. license and bearing the U.S. license number on its labeling may be imported into the U.S. unless the unlicensed version of allergenic product has an Investigational New Drug (IND) application in effect with the Center for Biologics Evaluation and Research
Quoted from the “Reason for Alert” section of the FDA page for 57-15, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.
Firms named on 57-15
| Firm | Country | Listed since | |
|---|---|---|---|
| Dormer Laboratories Inc91 Kelfield St Unit 5 , Etobicoke, Ontario CANADA | Canada | 10 Sep 200916 yr | |
| Chemotechnique DiagnosticsUnknown Street , Malmo, SWEDEN | Sweden | 10 Sep 200916 yr | |
| Chemotechnique DiagnosticsBox 80 28042 , Tygelsjo, SWEDEN | Sweden | 10 Sep 200916 yr | |
| Mcewen Laboratories Limited12 Horseshoe Park , Reading, WBK UNITED KINGDOM | United Kingdom | 14 May 201016 yr |