Famar Health Care Services Madrid S.A. · 66-41 · SPAIN
For Famar Health Care Services Madrid S.A. · 66-41 · SPAIN, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is SPAIN; product is Essentiale N | Essentiale N; product code is 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 06/30/2025; address is Avenida Leganes 62 , Alcorcon, Madrid SPAIN, verified against its source on 2026-09-16.
- Firm
- Famar Health Care Services Madrid S.A. verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- SPAIN verified
- Address
- Avenida Leganes 62 , Alcorcon, Madrid SPAIN verified
- Date published
- 06/30/2025 verified
- Product code
- 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- Essentiale N | Essentiale N each item verified
- FDA notes
- Product appears to be unapproved new drug in violation of section 505(a) of the FD&C Act. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | Product appears to be unapproved new drug in violation of section 505(a) of the FD&C Act. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. each item verified
What the source says
Famar Health Care Services Madrid S.A. Date Published : 06/30/2025 Avenida Leganes 62 , Alcorcon, Madrid SPAIN 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 06/30/2025 Desc: Essentiale N Notes: Product appears to be unapproved new drug in violation of section 505(a) of the FD&C Act. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/30/2025 Desc: Essentiale N Notes: Product appears to be unapproved new drug in violation of section 505(a) of the FD&C Act. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)].
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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