LABORATOIRES FILL-MED · 66-41 · FRANCE
For LABORATOIRES FILL-MED · 66-41 · FRANCE, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is FRANCE; product is NCTF 135 HA | 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 | 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 A - - 99 Vitamin, 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 | 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 2026-09-16.
- 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 A - - 99 Vitamin, 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 | 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 | 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 | 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 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 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)]. 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)]. 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)].
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html