# ABIO Materials Co., Ltd · 66-41 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Giheung , 719 16-25, Dongbaekjungang-Ro 16beon-Gil , Yongin, Gyeonggi KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 10/26/2016 _(verified: appears in the quote below)_
- **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) _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **FDA notes:** Medical claims on product labels | Medical claims on product labels _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).