ARSSI ALLIANCE LLC · 99-39 · ARMENIA
For ARSSI ALLIANCE LLC · 99-39 · ARMENIA, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is ARMENIA; product is Immune Booster Antiviral | Immune Booster Antiviral; product code is 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 08/25/2023; address is 24 5.Ovanisyan Str. , Yerevan, Yerevan ARMENIA, verified against its source on 2026-09-16.
- Firm
- ARSSI ALLIANCE LLC verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- ARMENIA verified
- Address
- 24 5.Ovanisyan Str. , Yerevan, Yerevan ARMENIA verified
- Date published
- 08/25/2023 verified
- Product code
- 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- Immune Booster Antiviral | Immune Booster Antiviral each item verified
- FDA notes
- The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) because the label fails to declare the net quantity of contents, as required by 21 CFR 101.7. Section 403(i)(2) in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36 and 101.9. Section 403(s)(2)(B) because the label fails to identify the product using the term “dietary supplement” in accordance with 21 CFR 101.3(g). Section 403(s)(2)(C) because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Section 403(y) in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. | he article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) because the label fails to declare the net quantity of contents, as required by 21 CFR 101.7. Section 403(i)(2) in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36 and 101.9. Section 403(s)(2)(B) because the label fails to identify the product using the term “dietary supplement” in accordance with 21 CFR 101.3(g). Section 403(s)(2)(C) because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Section 403(y) in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. each item verified
What the source says
ARSSI ALLIANCE LLC Date Published : 08/25/2023 24 5.Ovanisyan Str. , Yerevan, Yerevan ARMENIA 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/25/2023 Desc: Immune Booster Antiviral Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) because the label fails to declare the net quantity of contents, as required by 21 CFR 101.7. Section 403(i)(2) in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36 and 101.9. Section 403(s)(2)(B) because the label fails to identify the product using the term “dietary supplement” in accordance with 21 CFR 101.3(g). Section 403(s)(2)(C) because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Section 403(y) in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 08/25/2023 Desc: Immune Booster Antiviral Notes: he article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) because the label fails to declare the net quantity of contents, as required by 21 CFR 101.7. Section 403(i)(2) in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36 and 101.9. Section 403(s)(2)(B) because the label fails to identify the product using the term “dietary supplement” in accordance with 21 CFR 101.3(g). Section 403(s)(2)(C) because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Section 403(y) in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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