Reference Source

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
Sourceaccessdata.fda.gov
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Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

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