# Zhuhai Aofute Medical Technology Co., Ltd. · 66-41 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Zhuhai Aofute Medical Technology Co., Ltd. · 66-41 · CHINA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is CHINA; product is Magic Spray for Pain Relief | Magic Spray for Pain Relief | Magic Spray for Pain Relief | Magic Spray for Pain Relief | Magic Spray for Pain Relief | Magic Spray for Pain Relief | Magic Spray for Pain Relief; product code is 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs; date published is 03/05/2020; address is Building 1 Room 202 , No. 33 Yong South Rd; Nanshui Zhen Jinwan , Zhuhai, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** Zhuhai Aofute Medical Technology Co., Ltd. _(verified: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** CHINA _(verified: appears in the quote below)_
- **Address:** Building 1 Room 202 , No. 33 Yong South Rd; Nanshui Zhen Jinwan , Zhuhai, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 03/05/2020 _(verified: appears in the quote below)_
- **Product code:** 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs _(verified: each item appears in the quote below)_
- **Product:** Magic Spray for Pain Relief | Magic Spray for Pain Relief | Magic Spray for Pain Relief | Magic Spray for Pain Relief | Magic Spray for Pain Relief | Magic Spray for Pain Relief | Magic Spray for Pain Relief _(verified: each item appears in the quote below)_
- **FDA notes:** Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling. | Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling. | Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling. | Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling. | Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling. | Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling. | Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling. _(verified: each item appears in the quote below)_

## What the source says

> Zhuhai Aofute Medical Technology Co., Ltd. Date Published : 03/05/2020 Building 1 Room 202 , No. 33 Yong South Rd; Nanshui Zhen Jinwan , Zhuhai, Guangdong CHINA 60 - - - -- Human and Animal Drugs Date Published: 03/05/2020 Desc: Magic Spray for Pain Relief Notes: Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling. 61 - - - -- Human and Animal Drugs Date Published: 03/05/2020 Desc: Magic Spray for Pain Relief Notes: Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling. 62 - - - -- Human and Animal Drugs Date Published: 03/05/2020 Desc: Magic Spray for Pain Relief Notes: Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling. 63 - - - -- Human and Animal Drugs Date Published: 03/05/2020 Desc: Magic Spray for Pain Relief Notes: Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling. 64 - - - -- Human and Animal Drugs Date Published: 03/05/2020 Desc: Magic Spray for Pain Relief Notes: Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling. 65 - - - -- Human and Animal Drugs Date Published: 03/05/2020 Desc: Magic Spray for Pain Relief Notes: Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling. 66 - - - -- Human and Animal Drugs Date Published: 03/05/2020 Desc: Magic Spray for Pain Relief Notes: Product appears to be adulterated within the meaning of section 501 (a)(2)(B) of the Act in that the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements. Product is a "drug" as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Product is intended for use as an external analgesic. Product is a new drug as formulated and labeled, within the meaning of section 201(p) of the FD&C Act, because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).