LABORATOIRES FILL-MED · 66-41 · FRANCE
For LABORATOIRES FILL-MED, import alert is 66-41; country is FRANCE; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product is NCTF 135 HA | NCTF 135 HA | All Drugs and Drug Products | All Drugs and Drug Products | All Drugs and Drug Products | All Drugs and Drug Products | All Drugs and Drug Products | NCTF 135 HA | All Drugs and Drug Products | NCTF 135 HA | NCTF 135 HA; product code is 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 54 - D - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr | 54 - E - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr | 54 - F - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr | 54 - G - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr | 54 - I - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational | 54 A - - 99 Vitamin, N.E.C. | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 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 | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 87 M - - OZ Acid, hyaluronic, intraarticular; date published is 10/15/2025; address is 38 Cours Albert Ier , Paris, Paris FRANCE, verified against its source on 2026-10-01.
- Firm
- LABORATOIRES FILL-MED verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- FRANCE verified
- Address
- 38 Cours Albert Ier , Paris, Paris FRANCE verified
- Date published
- 10/15/2025 verified
- Product code
- 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 54 - D - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr | 54 - E - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr | 54 - F - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr | 54 - G - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr | 54 - I - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational | 54 A - - 99 Vitamin, N.E.C. | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 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 | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 87 M - - OZ Acid, hyaluronic, intraarticular each item verified
- Product
- NCTF 135 HA | NCTF 135 HA | All Drugs and Drug Products | All Drugs and Drug Products | All Drugs and Drug Products | All Drugs and Drug Products | All Drugs and Drug Products | NCTF 135 HA | All Drugs and Drug Products | NCTF 135 HA | NCTF 135 HA each item verified
- FDA notes
- “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. | “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. | “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. | “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. | “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. | “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. | “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. | “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. | All Drugs and Drug Products “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. | “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. | All Drugs and Drug Products “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. | All Drugs and Drug Products “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. | All Drugs and Drug Products “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. | All Drugs and Drug Products “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. | All Drugs and Drug Products “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. | All Drugs and Drug Products “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. | All Drugs and Drug Products “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. | All Drugs and Drug Products “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. | “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. | “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. each item verified
What the source says
LABORATOIRES FILL-MED Date Published : 10/15/2025 38 Cours Albert Ier , Paris, Paris FRANCE
— accessdata.fda.gov, retrieved 2026-09-24
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 10/15/2025 Desc: NCTF 135 HA Notes: “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 10/15/2025 Desc: NCTF 135 HA Notes: “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. 54 - D - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr Date Published: 10/15/2025 Desc: All Drugs and Drug Products Notes: “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. 54 - E - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr Date Published: 10/15/2025 Desc: All Drugs and Drug Products Notes: “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. 54 - F - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr Date Published: 10/15/2025 Desc: All Drugs and Drug Products Notes: “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. 54 - G - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr Date Published: 10/15/2025 Desc: All Drugs and Drug Products Notes: “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. 54 - I - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational Date Published: 10/15/2025 Desc: All Drugs and Drug Products Notes: “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. 54 A - - 99 Vitamin, N.E.C. Date Published: 10/15/2025 Desc: NCTF 135 HA Notes: “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 10/15/2025 Notes: All Drugs and Drug Products “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. 56 - - - -- Antibiotics (Human/Animal) Date Published: 10/15/2025 Desc: All Drugs and Drug Products Notes: “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 10/15/2025 Notes: All Drugs and Drug Products “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. 60 - - - -- Human and Animal Drugs Date Published: 10/15/2025 Notes: All Drugs and Drug Products “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. 61 - - - -- Human and Animal Drugs Date Published: 10/15/2025 Notes: All Drugs and Drug Products “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. 62 - - - -- Human and Animal Drugs Date Published: 10/15/2025 Notes: All Drugs and Drug Products “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. 63 - - - -- Human and Animal Drugs Date Published: 10/15/2025 Notes: All Drugs and Drug Products “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. 64 - - - -- Human and Animal Drugs Date Published: 10/15/2025 Notes: All Drugs and Drug Products “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. 65 - - - -- Human and Animal Drugs Date Published: 10/15/2025 Notes: All Drugs and Drug Products “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. 66 - - - -- Human and Animal Drugs Date Published: 10/15/2025 Notes: All Drugs and Drug Products “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 10/15/2025 Desc: NCTF 135 HA Notes: “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)]. 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 10/15/2025 Desc: NCTF 135 HA Notes: “NCTF 135 HA” is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved New Drug, Section 505(a)].
— all from accessdata.fda.gov, retrieved 2026-09-24
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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