# FICOSOTA LTD · 66-40 · BULGARIA — FDA import alert red lists: firms subject to detention without physical examination

For FICOSOTA LTD · 66-40 · BULGARIA, 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 BULGARIA; product is All Drug and Drug Products | All Drug and Drug Products; product code is 53 A - - 02 Lotions, Oils, Powders and Creams (Baby Products) | 53 A - - 99 Other Baby 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 01/10/2020; address is Madara Str. 48, Site 2 , Shumen, Shumen BULGARIA, verified against its source on 2026-09-16.

- **Firm:** FICOSOTA LTD _(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:** BULGARIA _(verified: appears in the quote below)_
- **Address:** Madara Str. 48, Site 2 , Shumen, Shumen BULGARIA _(verified: appears in the quote below)_
- **Date published:** 01/10/2020 _(verified: appears in the quote below)_
- **Product code:** 53 A - - 02 Lotions, Oils, Powders and Creams (Baby Products) | 53 A - - 99 Other Baby 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 _(verified: each item appears in the quote below)_
- **FDA notes:** For Industry Code 53, only drug and drug products are subject to DWPE under this notice. | For Industry Code 53, only drug and drug products are subject to DWPE under this notice. | 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

> FICOSOTA LTD Date Published : 01/10/2020 Madara Str. 48, Site 2 , Shumen, Shumen BULGARIA 53 A - - 02 Lotions, Oils, Powders and Creams (Baby Products) Date Published: 01/10/2020 Desc: All Drug and Drug Products Notes: For Industry Code 53, only drug and drug products are subject to DWPE under this notice. 53 A - - 99 Other Baby Products, N.E.C. Date Published: 01/10/2020 Desc: All Drug and Drug Products Notes: For Industry Code 53, only drug and drug products are subject to DWPE under this notice. 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 01/10/2020 Notes: All Drug and Drug Products 56 - - - -- Antibiotics (Human/Animal) Date Published: 01/10/2020 Notes: All Drug and Drug Products 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 01/10/2020 Notes: All Drug and Drug Products 61 - - - -- Human and Animal Drugs Date Published: 01/10/2020 Notes: All Drug and Drug Products 62 - - - -- Human and Animal Drugs Date Published: 01/10/2020 Notes: All Drug and Drug Products 63 - - - -- Human and Animal Drugs Date Published: 01/10/2020 Notes: All Drug and Drug Products 64 - - - -- Human and Animal Drugs Date Published: 01/10/2020 Notes: All Drug and Drug Products 65 - - - -- Human and Animal Drugs Date Published: 01/10/2020 Notes: All Drug and Drug Products 66 - - - -- Human and Animal Drugs Date Published: 01/10/2020 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/).