FDA import alert
Import Alert 99-34
DETENTION WITHOUT PHYSICAL EXAMINATION OF DRUGS OR MEDICAL DEVICES FROM FIRMS WITHOUT A VALID DRUG OR MEDICAL DEVICE REGISTRATION AND/OR LISTING
67
Red-list entries
0
Green-list entries
19
Countries
2026-07-06
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 30 of 67 entries — search a specific firm on the free checker.
AI DE DIAGNOSTIC CO LTD
11/22/2024
China · Anesthesiology; Cardiovascular; Chemistry
AI DE Diagnostic Co., Ltd
11/22/2024
China · Anesthesiology; Cardiovascular; Chemistry
BEIJING YUNTIAN HUAKANG TEC. CO.
10/11/2022
China · Unit, Oral Irrigation; Toothbrush, Powered
BRIGHT SUNWAY LIMITED
06/12/2026
China · Anesthesiology; Cardiovascular; Dental
Changzhou Jialing Medicine Industry Co. Ltd.
03/29/2013
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Changzhou Wujin Zhengping Shuangma Chemical Plant
03/29/2013
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
FOSHAN SUNDREAM ELECTRONICS CO.,LTD
02/02/2024
China · Hearing-Aid, Air-Conduction; Hearing Aid, Air-Conduction, Over the Counter; Sterilizer, Dry Heat
Guangzhou Jimy Facial
02/03/2015
China · Anesthesiology; Cardiovascular; Dental
JIANGSU SUHANG MEDICAL EQUIPMENT
02/24/2022
China · Anesthesiology; Cardiovascular; Dental
JIANGSU TAIPEI IMPORT & EXPORT
02/24/2022
China · Anesthesiology; Cardiovascular; Dental
NANJING CLEAN ENERGY ELECTRONIC TECHNOLOGY CO.,LTD.
05/05/2026
China · Device, Medical Examination, AC Powered; Device, Biofeedback
NINGBO YIXIN INTERNATIONAL TRADING CO.,LTD
05/05/2026
China · Device, Medical Examination, AC Powered; Device, Biofeedback
SHANGHAI BAOBANG MEDICAL EQUIPMENT CO.,LTD.
07/05/2022
China · Animal Medical Devices, NEC, Animal (Non-Food Producing), non-Rx, Non-Sterile; Compressor, Air, Portable; Chamber, Hyperbaric
SHENZHEN TECHNOLOGY CO LTD
10/07/2024
China · Light Based over the counter wrinkle reduction; Over-the-counter powered red/blue light based laser for acne; Stimulator, Transcutaneous Electrical, for Cosmetic Use
Shanghai Kindmax Sports Products Co.,Ltd
10/17/2014
China · Anesthesiology; Cardiovascular; Dental
Shenzhen Sibo Indl
05/04/2015
China · Massager, Therapeutic, Electric
Sunny Optoelectronic Tech Co.Ltd
02/19/2015
China · Powered laser surgical instruments
Zhejiang Xianju Chemical Pharmaceutical Factory
03/29/2013
China · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
COTE DAZUR PHARMACY
07/06/2026
France · Cosmetics; Anesthesiology; Cardiovascular
I.MANAGEMENT
08/02/2023
France · Other Cosmetic and Cosmetic Products, N.E.C.; Electrode, Cutaneous; Stimulator, Transcutaneous Electrical, for Cosmetic Use
SARL PARAZER
11/17/2025
France · Anesthesiology; Cardiovascular; Dental
ALTRUAN
07/22/2025
Germany · Chemistry; General Hospital/Personal Use; Immunology
ALTRUAN GMBH
07/22/2025
Germany · Chemistry; General Hospital/Personal Use; Immunology
MORYSKIN GMBH
08/29/2025
Germany · Anesthesiology; Cardiovascular; Chemistry
MORYSKIN GMBH
08/29/2025
Germany · Anesthesiology; Cardiovascular; Chemistry
MorySkin GmbH
08/29/2025
Germany · Anesthesiology; Cardiovascular; Chemistry
E FILLERS SA
07/06/2026
Greece · Cosmetics; Anesthesiology; Cardiovascular
GREEN ISLAND INTERNATIONAL TCM GROUP LIMITED
08/08/2014
Hong Kong SAR · Stimulator, Nerve, Transcutaneous, Over-The-Counter
IPULSE MEDICAL LTD.
09/08/2022
Hong Kong SAR · Stimulator, Nerve, Transcutaneous, For Pain Relief; Nerve, Stimulator, Electrical, Percutaneous (PENS) for Pain Relief; Stimulator, Nerve, Transcutaneous, Over-The-Counter
Peking Medicine Manufactory
03/29/2013
Hong Kong SAR · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
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