# MAKRA KOZMETIKA D.O.O. · 66-40 · SLOVENIA — FDA import alert red lists: firms subject to detention without physical examination

For MAKRA KOZMETIKA D.O.O. · 66-40 · SLOVENIA, import alert is 66-40; import alert name is "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"; country is SLOVENIA; product is All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products; product code is 53 L - - -- Skin Care Prep | 53 M - - -- Suntan Preparations | 53 U - - -- Cosmetic Prods Containing Animal By Prod (Other) | 53 Y - - -- Cosmetics and Cosmetic Products,n.e.c. | 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; date published is 09/25/2024; address is Kolodvorska Cesta 2 Slo , Kranj, SLOVENIA, verified against its source on 2026-09-16.

- **Firm:** MAKRA KOZMETIKA D.O.O. _(verified: appears in the quote below)_
- **Import alert:** 66-40
- **Import alert name:** "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"
- **Country:** SLOVENIA _(verified: appears in the quote below)_
- **Address:** Kolodvorska Cesta 2 Slo , Kranj, SLOVENIA _(verified: appears in the quote below)_
- **Date published:** 09/25/2024 _(verified: appears in the quote below)_
- **Product code:** 53 L - - -- Skin Care Prep | 53 M - - -- Suntan Preparations | 53 U - - -- Cosmetic Prods Containing Animal By Prod (Other) | 53 Y - - -- Cosmetics and Cosmetic Products,n.e.c. | 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 _(verified: each item appears in the quote below)_
- **Product:** All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products _(verified: each item appears in the quote below)_
- **FDA notes:** All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products _(verified: each item appears in the quote below)_

## What the source says

> MAKRA KOZMETIKA D.O.O. Date Published : 09/25/2024 Kolodvorska Cesta 2 Slo , Kranj, SLOVENIA 53 L - - -- Skin Care Prep Date Published: 09/25/2024 Desc: All Drug and Drug Products 53 M - - -- Suntan Preparations Date Published: 09/25/2024 Desc: All Drug and Drug Products 53 U - - -- Cosmetic Prods Containing Animal By Prod (Other) Date Published: 09/25/2024 Desc: All Drug and Drug Products 53 Y - - -- Cosmetics and Cosmetic Products,n.e.c. Date Published: 09/25/2024 Desc: All Drug and Drug Products 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 09/25/2024 Notes: All Drug and Drug Products 56 - - - -- Antibiotics (Human/Animal) Date Published: 09/25/2024 Notes: All Drug and Drug Products 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 09/25/2024 Notes: All Drug and Drug Products 60 - - - -- Human and Animal Drugs Date Published: 09/25/2024 Notes: All Drug and Drug Products 61 - - - -- Human and Animal Drugs Date Published: 09/25/2024 Notes: All Drug and Drug Products 62 - - - -- Human and Animal Drugs Date Published: 09/25/2024 Notes: All Drug and Drug Products 63 - - - -- Human and Animal Drugs Date Published: 09/25/2024 Notes: All Drug and Drug Products 64 - - - -- Human and Animal Drugs Date Published: 09/25/2024 Notes: All Drug and Drug Products 65 - - - -- Human and Animal Drugs Date Published: 09/25/2024 Notes: All Drug and Drug Products 66 - - - -- Human and Animal Drugs Date Published: 09/25/2024 Notes: All Drug and Drug Products

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_189.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/).