FDA import alert
Import Alert 89-18
Detention Without Physical Examination of Filtering Facepiece Respirators (FFR)
33
Red-list entries
0
Green-list entries
1
Countries
2021-06-22
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
| Country | Entries |
|---|---|
| China | 33 |
Firms on this red list
Showing 30 of 33 entries — search a specific firm on the free checker.
ANSHUN HEALTH AND MEDICAL TECHNOLOGY CO LTD
07/31/2020
China · Anesthesiology; Cardiovascular; Dental
Aab (China) Co.,Ltd
07/07/2020
China · Anesthesiology; Cardiovascular; Dental
CTT Co., Ltd
07/07/2020
China · Anesthesiology; Cardiovascular; Dental
Chuzhou Qiao Dong Industrial Co, Ltd
07/07/2020
China · Anesthesiology; Cardiovascular; Dental
DADDYBABY CO.,LTD
07/07/2020
China · Anesthesiology; Cardiovascular; Dental
DONG GUAN KING YEAR PAPER PRODUC
07/16/2020
China · Anesthesiology; Cardiovascular; Dental
DONGGUAN HUAGANG COMMUNICATION TECHNOLOGY CO., LTD.
07/07/2020
China · Anesthesiology; Cardiovascular; Dental
DONGGUAN LEIHUO MEDICAL DEVICE CO LTD
07/07/2020
China · Anesthesiology; Cardiovascular; Dental
DONGGUAN XIANDA MEDICAL EQUIPMENT CO LTD
07/07/2020
China · Anesthesiology; Cardiovascular; Dental
FOSHAN NANHAI WEIJIAN SAN BANG PROTECTIVE PRODUCTS TECHNOLOG
07/29/2020
China · Anesthesiology; Cardiovascular; Dental
GUANGDONG FEI FAN MSTAR TECHNOLOGY LTD
07/29/2020
China · Anesthesiology; Cardiovascular; Dental
GUANGDONG KAPER PROTECTION TECHNOLOGY CO., LTD
07/13/2020
China · Anesthesiology; Cardiovascular; Dental
GUANGDONG NAFEI INDUST HOLDING
07/07/2020
China · Anesthesiology; Cardiovascular; Dental
GUANGDONG QIAN JING TESTING CO., LTD.
07/07/2020
China · Anesthesiology; Cardiovascular; Dental
GUANGZHOU AIYINMEI CO LTD
07/31/2020
China · Anesthesiology; Cardiovascular; Dental
GUANGZHOU SUNJOY AUTO SUPPLIES CO., LTD.
07/07/2020
China · Anesthesiology; Cardiovascular; Dental
GUIZHOU BOCAI MEDICAL DEVICES CO LTD
07/31/2020
China · Anesthesiology; Cardiovascular; Dental
Guangdong For You Essentials Manufacturing Co., Ltd
07/07/2020
China · Anesthesiology; Cardiovascular; Dental
HONGRITA PRECISION COMPONENT ZHO
06/22/2021
China · Accessory, Surgical Apparel; Respirator, surgical; Face mask (except N95 respirator) for general public/healthcare personnel per IIE guidance
Huizhou Jiahe Cube Technology Co., Ltd
07/29/2020
China · Anesthesiology; Cardiovascular; Dental
IMPROVE MEDICAL (HUNAN) CO., LTD.
07/31/2020
China · Anesthesiology; Cardiovascular; Dental
JIANGSU WEICHUANGLI NEW MATERIALS CO., LTD.
07/31/2020
China · Anesthesiology; Cardiovascular; Dental
JIANGXI HORNET INDUSTRIAL COMPANY LIMITED
07/07/2020
China · Anesthesiology; Cardiovascular; Dental
MEDICAL DEVICE BRANCH OF ZHANGZHOU EASEPAL INDUSTRIAL CO.,LT
07/30/2020
China · Anesthesiology; Cardiovascular; Dental
MINGJIANG MEDICAL SUPPLIES CO LTD
07/07/2020
China · Anesthesiology; Cardiovascular; Dental
NINGBO YIXIN INTELLINGENTIZED SCIENCE AND TECHNOLOGY CO., LTD
07/07/2020
China · Mask, Scavenging; Mask, Surgical; Accessory, Surgical Apparel
QINGDAO ORPHILA MEDICAL TECHNOLOGY Co Limited
08/04/2020
China · Anesthesiology; Cardiovascular; Dental
SHANDONG DADDY'S CHOICE HEALTH SCIENCE AND TECHNOLOGY CO LTD
07/31/2020
China · Anesthesiology; Cardiovascular; Dental
TIANJIN BENMO MEDICAL EQUIPMENT CO., LTD.
07/31/2020
China · Anesthesiology; Cardiovascular; Dental
YIWU HENGHAO HOUSEHOLD PRODUCTS CO.,LTD
07/07/2020
China · Anesthesiology; Cardiovascular; Dental
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