FDA import refusals
FDA import refusals from Slovakia
Food, dietary supplements and animal food · October 2016 to October 22, 2024 · how the data is collected
FDA refused 14 shipment lines from Slovakia between October 2016 and October 2024, including 4 in 2024 through October 22, 2024; the most common charges were UNAPPROVED, LABELING and LACKS N/C, and the most refused category was dietary supplements.
Data from FDA public records, last checked .
- 14
- refused shipment lines since October 2016
- 4
- refused so far in 2024
- 10
- Slovakia firms with an FDA record
- 2
- firms on an active import alert
Refusals from Slovakia by year
Shipment lines FDA refused each year. The table has the same numbers as the chart.
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2024 | 4 | |
| 2022 | 1 | |
| 2020 | 2 | |
| 2018 | 5 | +150% |
| 2017 | 2 |
Why FDA refused Slovakia shipment lines
FDA records a charge code on each refused line; one line can carry several. Each code opens FDA's official statement and the countries and products behind it.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| UNAPPROVED | Unapproved new drug | 6 | 21% |
| LABELING | Fair Packaging and Labeling Act | 3 | 11% |
| LACKS N/C | Net quantity statement missing | 3 | 11% |
| NO ENGLISH | Required label information not in English | 3 | 11% |
| NUTRIT LBL | Nutrition information missing from label | 3 | 11% |
| LIST INGRE | Ingredients not listed | 2 | 7% |
| NCONTACT | No U.S. adverse event contact on supplement label | 2 | 7% |
| NEEDS FCE | Processor not registered for canned or acidified foods | 2 | 7% |
| NO PROCESS | No scheduled process filed | 2 | 7% |
| USUAL NAME | Common or usual name missing | 2 | 7% |
What FDA refused from Slovakia, by product category
FDA product categories, most refused first. Open a category for its product, charge and firm tables.
| Category | Most refused products | Lines |
|---|---|---|
| Dietary supplementsVitamins, Minerals, Proteins, and Unconventional Dietary Specialties | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.; Vitamin, n.e.c. | 6 |
| Chocolate and cocoaChocolate and Cocoa Products | Mixed or assorted chocolate candies (bars, boxes, loose form), with nuts and fruit; Chocolate candy bar, without nuts and fruit | 5 |
| Meal replacementsDietary Conventional Foods and Meal Replacements | Meal replacements (not labeled for treatment of disease); Dietary conventional foods, n.e.c. | 3 |
Most refused products from Slovakia
FDA's product descriptions on the refused lines, grouped case-insensitively.
| Product | Lines | Share |
|---|---|---|
| Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. | 5 | 35.7% |
| Mixed or assorted chocolate candies (bars, boxes, loose form), with nuts and fruit | 4 | 28.6% |
| Meal replacements (not labeled for treatment of disease) | 2 | 14.3% |
| Chocolate candy bar, without nuts and fruit | 1 | 7.1% |
| Dietary conventional foods, n.e.c. | 1 | 7.1% |
| Vitamin, n.e.c. | 1 | 7.1% |
FDA import alerts that list Slovakia firms
3 alerts list at least one firm in Slovakia: 2 firms on a red list, 2 firms on any list.
Slovakia firms with the most FDA records
Counts are FDA records in SupplierRadar's data (refusals, import alert listings and other events), not a ranking of quality.
| Firm | City | FDA records |
|---|---|---|
| Mondelez SR Production SRO | Bratislava | 3 |
Latest refusals from Slovakia
The 14 most recent refused lines, each with its FDA source.
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Agepha Pharma S.R.O.Senec, Slovakia | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Agepha Pharma S.R.O.Senec, Slovakia | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Agepha Pharma S.R.O.Senec, Slovakia | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Agepha Pharma S.R.O.Senec, Slovakia | Dietary conventional foods, n.e.c | LACKS N/CHEALTH C | Source | |
| Innopharma S.R.O.Dunajska Streda, Slovakia | Vitamin, n.e.c | UNAPPROVED | Source | |
| Mondelez SrBratislava, Slovakia | Mixed or assorted chocolate candies (bars, boxes, loose form), with nuts and fruit | LACKS N/CUSUAL NAMENUTRIT LBL | Source | |
| Mondelez SrBratislava, Slovakia | Mixed or assorted chocolate candies (bars, boxes, loose form), with nuts and fruit | LACKS FIRMLACKS N/CNO ENGLISH+1 | Source | |
| Mondelez SR Production SROBratislava, Slovakia | Mixed or assorted chocolate candies (bars, boxes, loose form), with nuts and fruit | LABELING | Source | |
| Mondelez SR Production SROBratislava, Slovakia | Mixed or assorted chocolate candies (bars, boxes, loose form), with nuts and fruit | LABELING | Source | |
| Mondelez SR Production SROBratislava, Slovakia | Chocolate candy bar, without nuts and fruit | LABELING | Source | |
| Boos TradeKosice - Zapad, Slovakia | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LIST INGRENO ENGLISHNCONTACT+2 | Source | |
| Boos TradeKosice - Zapad, Slovakia | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LIST INGRENO ENGLISHNCONTACT+2 | Source | |
| Max Sport, S.R.O.Bratislava - Nove Mesto, Slovakia | Meal replacements (not labeled for treatment of disease) | NEEDS FCENO PROCESS | Source | |
| Max Sport, S.R.O.Bratislava - Nove Mesto, Slovakia | Meal replacements (not labeled for treatment of disease) | NEEDS FCENO PROCESS | Source |
Questions about FDA refusals from Slovakia
- How many Slovakia shipments did FDA refuse in 2024?
- FDA refused 4 shipment lines from Slovakia in 2024 through October 22, 2024.
- Why does FDA refuse food from Slovakia?
- FDA records a charge code on every refused shipment line. For Slovakia the most frequent are UNAPPROVED (unapproved new drug, 6 lines), LABELING (Fair Packaging and Labeling Act, 3 lines) and LACKS N/C (net quantity statement missing, 3 lines). A charge describes what FDA's reference table says about one shipment line; it is not a finding about every firm in the country.
- Which Slovakia firms have the most FDA refusals?
- In SupplierRadar's records the Slovakia firms with the most FDA records (refusals, import alert listings and other events) are Mondelez SR Production SRO (Bratislava) with 3 records. Each firm's page lists every record with its FDA source.
- Which FDA import alerts list Slovakia firms?
- As of October 26, 2026, 3 FDA import alerts list at least one firm in Slovakia. The alerts with the most Slovakia listings are Import Alert 34-02 (1 firm), Import Alert 45-02 (1 firm) and Import Alert 99-45 (1 firm).
- How many Slovakia firms are on an FDA import alert red list?
- As of October 26, 2026, 2 Slovakia firms are on the red list of at least one FDA import alert in SupplierRadar's records, and 2 firms are on any list.
All Slovakia suppliers with FDA records (3)
Every Slovakia firm in SupplierRadar's data with an active import alert, a warning letter or at least five FDA records, most recently active first. Each name opens the firm's FDA record history.
- Best Supps LtdBratislava
- Mondelez SR Production SROBratislava
- I.D.C. HoldingBratislava - Ruzinov
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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.