Reference Source

ABIO Materials Co., Ltd · 66-41 · KOREA (THE REPUBLIC OF)

For ABIO Materials Co., Ltd · 66-41 · KOREA (THE REPUBLIC OF), import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is KOREA (THE REPUBLIC OF); product is EXOS HAIR REGENERATION SET POWDER/SOLVENT | AAPE Adipo Series III Hair Ampoule | EXOS SKIN REGENERATION SET POWDER/SOLVENT | EXOS HAIR REGENERATION SET POWDER/SOLVENT | EXOS SKIN REGENERATION SET POWDER/SOLVENT | EXOS SKIN REGENERATION SET POWDER/SOLVENT | EXOS HAIR REGENERATION SET POWDER/SOLVENT | AAPE Adipo Series III Hair Ampoule; product code is 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. | 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 57 M - - 02 Hematopoietic Progenitor Cells (HPC), Apheresis | 57 M - - 02 Hematopoietic Progenitor Cells (HPC), Apheresis | 66 U - - 04 Hair (Natural Body Parts, Invivo Only); date published is 10/26/2016; address is Giheung , 719 16-25, Dongbaekjungang-Ro 16beon-Gil , Yongin, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

Firm
ABIO Materials Co., Ltd verified
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
KOREA (THE REPUBLIC OF) verified
Address
Giheung , 719 16-25, Dongbaekjungang-Ro 16beon-Gil , Yongin, Gyeonggi KOREA (THE REPUBLIC OF) verified
Date published
10/26/2016 verified
Product code
53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. | 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 57 M - - 02 Hematopoietic Progenitor Cells (HPC), Apheresis | 57 M - - 02 Hematopoietic Progenitor Cells (HPC), Apheresis | 66 U - - 04 Hair (Natural Body Parts, Invivo Only) each item verified
Product
EXOS HAIR REGENERATION SET POWDER/SOLVENT | AAPE Adipo Series III Hair Ampoule | EXOS SKIN REGENERATION SET POWDER/SOLVENT | EXOS HAIR REGENERATION SET POWDER/SOLVENT | EXOS SKIN REGENERATION SET POWDER/SOLVENT | EXOS SKIN REGENERATION SET POWDER/SOLVENT | EXOS HAIR REGENERATION SET POWDER/SOLVENT | AAPE Adipo Series III Hair Ampoule each item verified
FDA notes
Medical claims on product labels | Medical claims on product labels each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

ABIO Materials Co., Ltd Date Published : 10/26/2016 Giheung , 719 16-25, Dongbaekjungang-Ro 16beon-Gil , Yongin, Gyeonggi KOREA (THE REPUBLIC OF) 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. Date Published: 03/06/2025 Desc: EXOS HAIR REGENERATION SET POWDER/SOLVENT 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. Date Published: 10/26/2016 Desc: AAPE Adipo Series III Hair Ampoule Notes: Medical claims on product labels 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 03/06/2025 Desc: EXOS SKIN REGENERATION SET POWDER/SOLVENT 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 03/06/2025 Desc: EXOS HAIR REGENERATION SET POWDER/SOLVENT 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 03/06/2025 Desc: EXOS SKIN REGENERATION SET POWDER/SOLVENT 57 M - - 02 Hematopoietic Progenitor Cells (HPC), Apheresis Date Published: 03/06/2025 Desc: EXOS SKIN REGENERATION SET POWDER/SOLVENT 57 M - - 02 Hematopoietic Progenitor Cells (HPC), Apheresis Date Published: 03/06/2025 Desc: EXOS HAIR REGENERATION SET POWDER/SOLVENT 66 U - - 04 Hair (Natural Body Parts, Invivo Only) Date Published: 10/26/2016 Desc: AAPE Adipo Series III Hair Ampoule Notes: Medical claims on product labels

accessdata.fda.gov, retrieved 2026-09-15

Source

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