Reference Source

Zermat Internacional Sa De Cv · 66-41 · MEXICO

For Zermat Internacional Sa De Cv · 66-41 · MEXICO, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is MEXICO; product is Intimate Shampoo / Shampoo de Higiene Intima | Intimate Shampoo / Shampoo de Higiene Intima | Intimate Shampoo / Shampoo de Higiene Intima | Intimate Shampoo / Shampoo de Higiene Intima; product code is 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 U - - 10 Personal Cleanliness, Cosmetic products containing animal by-products (other animal by-products) | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C; date published is 11/08/2018; address is Torre 3 , Calzada Melchor Ocampo 193; Colonia Veronica Anzures , Miguel Hidalgo, Ciudad de Mexico MEXICO, verified against its source on 2026-09-16.

Firm
Zermat Internacional Sa De Cv verified
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
MEXICO verified
Address
Torre 3 , Calzada Melchor Ocampo 193; Colonia Veronica Anzures , Miguel Hidalgo, Ciudad de Mexico MEXICO verified
Date published
11/08/2018 verified
Product code
53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 U - - 10 Personal Cleanliness, Cosmetic products containing animal by-products (other animal by-products) | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. each item verified
Product
Intimate Shampoo / Shampoo de Higiene Intima | Intimate Shampoo / Shampoo de Higiene Intima | Intimate Shampoo / Shampoo de Higiene Intima | Intimate Shampoo / Shampoo de Higiene Intima each item verified
FDA notes
Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). | Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). | Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). | Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Zermat Internacional Sa De Cv Date Published : 11/08/2018 Torre 3 , Calzada Melchor Ocampo 193; Colonia Veronica Anzures , Miguel Hidalgo, Ciudad de Mexico MEXICO 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) Date Published: 11/08/2018 Desc: Intimate Shampoo / Shampoo de Higiene Intima Notes: Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. Date Published: 11/08/2018 Desc: Intimate Shampoo / Shampoo de Higiene Intima Notes: Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). 53 U - - 10 Personal Cleanliness, Cosmetic products containing animal by-products (other animal by-products) Date Published: 11/08/2018 Desc: Intimate Shampoo / Shampoo de Higiene Intima Notes: Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 11/08/2018 Desc: Intimate Shampoo / Shampoo de Higiene Intima Notes: Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA).

accessdata.fda.gov, retrieved 2026-09-15

Source

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