Reference Source

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

For ABIO Materials Co., Ltd, import alert is 66-41; country is KOREA (THE REPUBLIC OF); import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product is AAPE Adipo Series III Hair Ampoule | EXOS HAIR REGENERATION SET POWDER/SOLVENT | EXOS SKIN REGENERATION SET POWDER/SOLVENT | EXOS HAIR REGENERATION SET POWDER/SOLVENT | EXOS SKIN REGENERATION SET POWDER/SOLVENT | EXOS HAIR REGENERATION SET POWDER/SOLVENT | EXOS SKIN 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 2026-10-01.

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
AAPE Adipo Series III Hair Ampoule | EXOS HAIR REGENERATION SET POWDER/SOLVENT | EXOS SKIN REGENERATION SET POWDER/SOLVENT | EXOS HAIR REGENERATION SET POWDER/SOLVENT | EXOS SKIN REGENERATION SET POWDER/SOLVENT | EXOS HAIR REGENERATION SET POWDER/SOLVENT | EXOS SKIN 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)

— 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 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 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. Date Published: 03/06/2025 Desc: EXOS HAIR REGENERATION SET POWDER/SOLVENT 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 HAIR REGENERATION SET POWDER/SOLVENT 57 M - - 02 Hematopoietic Progenitor Cells (HPC), Apheresis Date Published: 03/06/2025 Desc: EXOS SKIN 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

— all from accessdata.fda.gov, retrieved 2026-09-24

Source

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