FDA import refusals
FDA import refusals from Sri Lanka
Food, dietary supplements and animal food · October 2016 to October 8, 2026 · how the data is collected
FDA refused 320 shipment lines from Sri Lanka between October 2016 and October 2026, including 34 in 2026 through October 8, 2026; the most common charges were FILTHY, UNAPPROVED and NUTRIT LBL, and the most refused category was seafood.
Data from FDA public records, last checked .
- 320
- refused shipment lines since October 2016
- 34
- refused so far in 2026
- 176
- Sri Lanka firms with an FDA record
- 44
- firms on an active import alert
Refusals from Sri Lanka by year
Shipment lines FDA refused each year. The table has the same numbers as the chart.
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2026 (to date) | 34 | |
| 2025 | 34 | +162% |
| 2024 | 13 | -35% |
| 2023 | 20 | +25% |
| 2022 | 16 | -56% |
| 2021 | 36 | +125% |
| 2020 | 16 | -65% |
| 2019 | 46 | -8% |
| 2018 | 50 | +2% |
| 2017 | 49 | |
| 2016 (from Oct) | 6 |
Why FDA refused Sri Lanka 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 |
|---|---|---|---|
| FILTHY | Filthy, putrid or decomposed substance | 106 | 35% |
| UNAPPROVED | Unapproved new drug | 57 | 19% |
| NUTRIT LBL | Nutrition information missing from label | 32 | 11% |
| SALMONELLA | Salmonella | 27 | 9% |
| NO PROCESS | No scheduled process filed | 19 | 6% |
| INADPRCCTL | Inadequate process controls | 15 | 5% |
| PESTICIDE | Pesticide chemical residue | 13 | 4% |
| UNSAFE COL | Color additive unsafe under section 721 | 13 | 4% |
| COLOR LBLG | Artificial coloring not declared | 11 | 4% |
| JUICEHACCP | Appears to have been prepared, packed, or held under insanitary conditions, or it may be injurious to… | 10 | 3% |
What FDA refused from Sri Lanka, by product category
FDA product categories, most refused first. Open a category for its product, charge and firm tables.
| Category | Most refused products | Lines |
|---|---|---|
| SeafoodFishery/Seafood Products | Tuna (albacore, yellowfin, bluefin, skipjack, etc.); Shrimp and prawns, aquaculture harvested fishery/seafood products; Swordfish | 87 |
| SpicesSpices, Flavors, and Salts | Cinnamon, cassia, ground, cracked (spice); Cinnamon, cassia, whole (spice); Curry powder, ground, cracked, without salt | 55 |
| Tropical and pit fruitFruit and Fruit Products (pit, subtropical and tropical fruits) | Coconut, subtropical and tropical fruit, juices, milk, creme, drinks and nectars; Tamarind, dried or paste; Jackfruit (subtropical and tropical fruit) | 50 |
| Dietary supplementsVitamins, Minerals, Proteins, and Unconventional Dietary Specialties | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.; Herbals & botanicals (not teas), n.e.c.; Herbals & botanical teas, n.e.c. | 40 |
| Bakery productsBakery Products, Doughs, Bakery Mixes, and Icings | Other bakery products, n.e.c.; Pastry (eclairs, cream puffs) custard or cream filled; Plain cookies,biscuits and wafers, n.e.c. | 15 |
| Coffee and teaCoffee and Tea | Tea, black; Tea, green; Tea, n.e.c. | 14 |
| Grains and starchWhole Grains, Milled Grain Products, and Starch | Rice, processed (packaged) n.e.c.; Malt, wheat | 13 |
| Vegetables (legumes and leafy)Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables) | Bean, corn, pea, dried or paste, n.e.c. (vegetable); Mung bean, dried or paste; Beans, corn, and pea, n.e.c. (vegetable) | 10 |
| Nuts and seedsNuts and Edible Seeds | Coconut, nut flour/meal; Coconut, shelled; Coconut, topping | 9 |
| Sauces and prepared mealsMultiple Food Dinners, Gravies, Sauces, and Specialties | Chili sauce; Curry sauce; Sauces, n.e.c. | 6 |
| Milk and butterMilk, Butter, and Dried Milk Products | Milk, dried; Fluid milk products, skim, 1%, 2%, whole and all flavored and modified (lactose reduced, ie) grade a; Fluid/dry milk products not elsewhere mentioned, n.e.c. | 4 |
| SweetenersFood Sweeteners (Nutritive) | Food sweetners (nutritive) n.e.c.; Glucose and corn syrup; Syrups and molasses, n.e.c. | 4 |
| Dressings and condimentsDressings and Condiments | Chutney; Condiments, n.e.c. | 3 |
| Soft drinks and waterSoft Drinks and Waters | Carbonated soft drink, n.e.c.; Soft drink, subtropical or tropical fruit flavored, noncarbonated | 2 |
| Beverage basesBeverage Bases | Beverage base, subtropical or tropical fruit; Imitation fruit flavored beverage base, n.e.c. | 2 |
| Snack foodsSnack Food Items | Seafood flavored snacks, baked (meat/poultry/seafood snacks) | 1 |
| Ice creamIce Cream and Related Products | Sherbet mix | 1 |
| Root vegetables and mushroomsVegetables and Vegetable Products (root and tuber vegetables, fungi) | Garlic bulb, dried or paste | 1 |
| Vegetable oilsVegetable Oils (Includes Olive Oil) | Coconut oil, refined, single ingredient | 1 |
| Candy and chewing gumCandy without Chocolate, Candy Specialties, and Chewing Gum | Candy without chocolate n.e.c. | 1 |
| Meal replacementsDietary Conventional Foods and Meal Replacements | Foods with supplemental nutrients added, with or without artifical sweetners | 1 |
Most refused products from Sri Lanka
FDA's product descriptions on the refused lines, grouped case-insensitively.
| Product | Lines | Share |
|---|---|---|
| Tuna (albacore, yellowfin, bluefin, skipjack, etc.) | 60 | 18.8% |
| Cinnamon, cassia, ground, cracked (spice) | 21 | 6.6% |
| Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. | 21 | 6.6% |
| Cinnamon, cassia, whole (spice) | 17 | 5.3% |
| Coconut, subtropical and tropical fruit, juices, milk, creme, drinks and nectars | 16 | 5.0% |
| Rice, processed (packaged) n.e.c. | 12 | 3.8% |
| Shrimp and prawns, aquaculture harvested fishery/seafood products | 12 | 3.8% |
| Tamarind, dried or paste | 12 | 3.8% |
| Tea, black | 9 | 2.8% |
| Curry powder, ground, cracked, without salt | 8 | 2.5% |
FDA import alerts that list Sri Lanka firms
15 alerts list at least one firm in Sri Lanka: 42 firms on a red list, 44 firms on any list.
| Alert | Covers | Red | Green |
|---|---|---|---|
| 45-02 | Foods with illegal or undeclared colors | 13 | |
| 99-19 | Food products: Salmonella | 12 | |
| 99-08 | Processed human and animal foods: pesticides | 5 | |
| 16-81 | Seafood products: Salmonella | 4 | |
| 16-105 | Fish products: decomposition, histamine or indole | 3 | |
| 16-125 | Refrigerated raw fish in reduced oxygen packaging | 3 | |
| 16-120 | Seafood from processors not in compliance with HACCP | 2 | |
| 23-12 | Coconut: microbiological contamination | 2 | |
| 99-35 | Fresh produce: insanitary conditions | 2 | |
| 99-38 | Low-acid canned/acidified foods: inadequate process control | 2 | |
| 99-39 | Imported foods that appear to be misbranded | 2 | |
| 99-42 | Foods: heavy metal (toxic element) contamination | 2 |
The 12 alerts with the most listings. All alerts are on the import alerts page.
Sri Lanka 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 |
|---|---|---|
| Taprobane Seafood (PVT) LTD. | Dankotuwa | 52 |
| Dru Era (Pvt) Ltd | Dehiwala | 45 |
| Lanka Canneries (Pvt) Ltd. | Gampaha District | 32 |
| Global Sea Foods Pvt Ltd - Unit 2 | Colombo | 19 |
| CIC Agri Produce Export | Maho | 12 |
| AMK Food Export (Pvt) Ltd | Homagama | 11 |
| Jaindi Export (PVT)Ltd | Dankotuwa | 11 |
| Uniworld Teas (Pvt) Ltd. | Mulleriyawa | 9 |
| Lanka Canneries (Pvt) Ltd. | Atthanagalla | 8 |
| GLOBAL SEA FOODS (Pvt) Ltd | Badalagama | 8 |
Latest refusals from Sri Lanka
The 20 most recent refused lines, each with its FDA source.
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Cinnamon, cassia, ground, cracked (spice) | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Cinnamon, cassia, ground, cracked (spice) | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Cinnamon, cassia, ground, cracked (spice) | ADDDRUGBIO | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Cinnamon, cassia, ground, cracked (spice) | ADDDRUGBIO | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Cinnamon, cassia, ground, cracked (spice) | ADDDRUGBIO | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | ADDDRUGBIO | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Cinnamon, cassia, ground, cracked (spice) | UNAPPROVED | Source |
Questions about FDA refusals from Sri Lanka
- How many Sri Lanka shipments did FDA refuse in 2026?
- FDA refused 34 shipment lines from Sri Lanka in 2026 through October 8, 2026, compared with 34 in 2025 (a full year).
- Why does FDA refuse food from Sri Lanka?
- FDA records a charge code on every refused shipment line. For Sri Lanka the most frequent are FILTHY (filthy, putrid or decomposed substance, 106 lines), UNAPPROVED (unapproved new drug, 57 lines) and NUTRIT LBL (nutrition information missing from label, 32 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 Sri Lanka firms have the most FDA refusals?
- In SupplierRadar's records the Sri Lanka firms with the most FDA records (refusals, import alert listings and other events) are Taprobane Seafood (PVT) LTD. (Dankotuwa) with 52 records, Dru Era (Pvt) Ltd (Dehiwala) with 45 records and Lanka Canneries (Pvt) Ltd. (Gampaha District) with 32 records. Each firm's page lists every record with its FDA source.
- Which FDA import alerts list Sri Lanka firms?
- As of October 26, 2026, 15 FDA import alerts list at least one firm in Sri Lanka. The alerts with the most Sri Lanka listings are Import Alert 45-02 (13 firms), Import Alert 99-19 (12 firms) and Import Alert 99-08 (5 firms).
- How many Sri Lanka firms are on an FDA import alert red list?
- As of October 26, 2026, 42 Sri Lanka firms are on the red list of at least one FDA import alert in SupplierRadar's records, and 44 firms are on any list.
All Sri Lanka suppliers with FDA records (51)
Every Sri Lanka 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.
- Dru Era (Pvt) LtdDehiwala
- Lanka Canneries (Pvt) Ltd.Gampaha District
- E-Silk Route Ventures (Pvt) Ltd.Rajagiriya
- E-Silk Route Ventures Pvt LtdGampaha District
- Eswaran Brothers Exports (PVT) LtdColombo 14
- Imperial Spices (Pvt) LtdMatale District
- Imperial Spices Pvt. Ltd.Kelaniya
- Ceylon Biscuits LtdPannipitiya
- Arunalu ProductsKatana
- Nestle Lanka PLCGonawila
- Lanka Canneries (Pvt) Ltd.Atthanagalla
- Uniworld Teas (Pvt) Ltd.Mulleriyawa
- Wijaya Products (Pvt) Ltd.Kalutara
- Joint Agri Products Ceylon (PVT) Ltd.Gampaha District
- Taprobane Seafood (PVT) LTD.Dankotuwa
- Consolidated Business Systems LimitedBoralesgamuwa
- AMK Food Export (Pvt) LtdHomagama
- CIC Agri Produce ExportMaho
- Global Sea Foods Pvt Ltd - Unit 2Colombo
- Maliban Biscuit Manufactories Ltd.Ratmalana
- Jaindi Export (PVT)LtdDankotuwa
- Link Natural Products Private LtdColombo
- GLOBAL SEA FOODS (Pvt) LtdBadalagama
- Northwest Fishery (Pvt) LtdDankotuwa
- Srs Fruit N Spices (Pvt) LtdColombo
- Srs Fruit N Spices (Pvt) LtdNegambo
- Pulses Splitting & Processing Industry (Pvt) Ltd.Gonawala
- Ceylon Royal Tea And SuppliesHomagama
- Foreconns CanneriesKalutara
- Prawn Ceylon (Pvt.) Ltd.Marawila
- Leela Exports & ImportsColombo
- Pan-Am Foods (Pvt) Ltd.Avissawella
- Saboor Chatoor (Private) LimitedColombo
- Global Sea Foods Pvt LtdColombo
- Bio Foods Pvt LtdKandy
- Euro-Scan ExportsColombo
- Pan Am Foods Ltd.Colombo
- J-Cey-Exports (Private) Ltd.Colombo
- Pan-Am FoodsCOLOMBO 7
- Ceylon Cold Stores PLCColombo
- Ceylon Cold Stores, Ltd.Colombo
- Delmege Forsyth & Co.(Exports) LtdColombo 10
- Delmege Medical Pvt LtdColombo
- Indiwary Aqua (Pvt) LtdChilaw
- Motha Cofectionery Works Ltd.Colombo 13
- Uruthira Bros LtdWattala
- A G ExportsColombo
- A.S. EnterprisesAmpitiya
- Lankan DelightGampaha District
- Mega TrendsColumbo
- Prime Food Products LtdColombo
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Buying from Sri Lanka?
Check each Sri Lanka supplier against every FDA record in one paste, free for five suppliers. Watch the ones you buy from and get the source the day a record changes.
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.