FDA import refusals
FDA import refusals from Italy
FDA refused 1,442 shipment lines from Italy between October 2016 and October 2026, including 77 in 2026 through October 8, 2026; the most common charges were NUTRIT LBL, UNSAFE COL and NO ENGLISH, and the most refused category was noodles and pasta.
Data from FDA public records, last checked .
- 1,442
- refused shipment lines since October 2016
- 77
- refused so far in 2026
- 1,299
- Italy firms with an FDA record
- 141
- firms on an active import alert
Refusals from Italy by year
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2026 (to date) | 77 | |
| 2025 | 131 | +30% |
| 2024 | 101 | +25% |
| 2023 | 81 | +5% |
| 2022 | 77 | +40% |
| 2021 | 55 | -59% |
| 2020 | 133 | -32% |
| 2019 | 196 | +1% |
| 2018 | 195 | -45% |
| 2017 | 357 | |
| 2016 (from Oct) | 39 |
Why FDA refused Italy shipment lines
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| NUTRIT LBL | Nutrition information missing from label | 365 | 22% |
| UNSAFE COL | Color additive unsafe under section 721 | 234 | 14% |
| NO ENGLISH | Required label information not in English | 196 | 12% |
| LIST INGRE | Ingredients not listed | 170 | 10% |
| PESTICIDE | Pesticide chemical residue | 152 | 9% |
| NO PROCESS | No scheduled process filed | 125 | 8% |
| STD IDENT | Does not conform to standard of identity | 122 | 7% |
| LACKS N/C | Net quantity statement missing | 111 | 7% |
| SUPPL GMP | Dietary supplement CGMP not met | 102 | 6% |
| NCONTACT | No U.S. adverse event contact on supplement label | 81 | 5% |
What FDA refused from Italy, by product category
| Category | Most refused products | Lines |
|---|---|---|
| Noodles and pastaMacaroni and Noodle Products | Spaghetti; Macaroni enriched; Alimentary paste | 334 |
| 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.; L-arginine (protein) | 253 |
| Tropical and pit fruitFruit and Fruit Products (pit, subtropical and tropical fruits) | Olives, green, (pit fruit); Citrus flavored imitation fruit, jam, jelly, preserves, marmalade, butter or candied; Olives (pit fruit) | 112 |
| Vegetables (legumes and leafy)Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables) | Tomatoes (fruit used as vegetable); Pepper, hot, n.e.c. (fruit used as vegetable); Tomatoes, with sauce | 105 |
| Nuts and seedsNuts and Edible Seeds | Pistachio, spread; Pistachio, paste; Nut, paste, n.e.c. | 74 |
| Candy and chewing gumCandy without Chocolate, Candy Specialties, and Chewing Gum | Chewing gum (without chocolate); Flavored candy, hard (live savers, etc.), without nuts and fruit (without chocolate); Candy without chocolate n.e.c. | 65 |
| Chocolate and cocoaChocolate and Cocoa Products | Chocolate and chocolate covered candy, with nuts or nut products, n.e.c. (not coconut); Chocolate and cocoa products, n.e.c.; Chocolate candy bar, without nuts and fruit | 60 |
| CheeseCheese and Cheese Products | Cheese, gorgonzola; Soft ripened cheese made from sheep's milk; Cheese, hard (chesire,esrum,fortina,fortine,kasseni,mozzarella,montasio,pecarino,port salut, etc) | 57 |
| Root vegetables and mushroomsVegetables and Vegetable Products (root and tuber vegetables, fungi) | Mushrooms and other fungi products, pieces and stems, sliced, n.e.c.; Truffle, fungi products, n.e.c.; Mushroom, morel, pieces and stems, sliced | 55 |
| Bakery productsBakery Products, Doughs, Bakery Mixes, and Icings | Plain cookies,biscuits and wafers, n.e.c.; Icings and icing mixes, n.e.c.; Other bakery products, n.e.c. | 49 |
| Vegetable oilsVegetable Oils (Includes Olive Oil) | Olive oil, refined, single ingredient; Virgin olive oil, crude; Oil stock olives, olive pomace | 49 |
| Grains and starchWhole Grains, Milled Grain Products, and Starch | Wheat flour, plain; Rice, processed (packaged) n.e.c.; Farina, wheat | 48 |
| SeafoodFishery/Seafood Products | Fish roe, fishery products, n.e.c.; Anchovy; Mullet | 36 |
| Sauces and prepared mealsMultiple Food Dinners, Gravies, Sauces, and Specialties | Sauces, n.e.c.; Basil sauce (with other ingredients); Garlic sauce | 36 |
| Soft drinks and waterSoft Drinks and Waters | Soft drinks and waters not mentioned elsewhere, n.e.c.; Bottled spring or mineral water; Soft drink, other fruit flavored, noncarbonated | 18 |
| Coffee and teaCoffee and Tea | Coffee, ground; Coffee, beans; Coffee, ground, decaffeinated | 14 |
| SpicesSpices, Flavors, and Salts | Saffron, ground, cracked (spice); Basil (sweet basil), natural extract or flavor (spice); Bay (laurel), ground, cracked (spice) | 13 |
| Dressings and condimentsDressings and Condiments | Balsamic vinegar (sweet, fruity flavor); Condiments, n.e.c.; Vinegar, n.e.c. | 12 |
| Ice creamIce Cream and Related Products | Ice cream and related products, n.e.c.; Ice cream and related product mixes (junket, etc.), n.e.c. | 9 |
| Berries and citrusFruit and Fruit Products (berries, citrus and core fruits) | Lemon, citrus fruit juices or concentrates; Apple, core fruit juices or concentrates; Berries, dried or paste, n.e.c. | 9 |
| SweetenersFood Sweeteners (Nutritive) | Honey; Cane sugar (sucrose) | 8 |
| Milk and butterMilk, Butter, and Dried Milk Products | Cream, sweet, whipping, table, etc.; Fluid/dry milk products not elsewhere mentioned, n.e.c. | 4 |
| Vine and other fruitFruit and Fruit Products (vine and other fruits) | Other fruits and fruit products, other fruit juices or concentrates, n.e.c. | 4 |
| Beverage basesBeverage Bases | Beverage base, berry, liquid; Beverage base, citrus, liquid | 4 |
| SoupsSoups | Mixed vegetable soup; Vegetable (single ingredient not mentioned elsewhere) soup | 4 |
| Meal replacementsDietary Conventional Foods and Meal Replacements | Foods with supplemental nutrients added, with or without artifical sweetners | 4 |
| Snack foodsSnack Food Items | Baked snack food, n.e.c.; Bread sticks (flavored or unflavored), bread snacks fried/oil cooked | 3 |
| Alcoholic beveragesAlcoholic Beverages | Wine, red (still) | 2 |
| Food additives (flavors and colors)Food Additives for Human Use (flavors, colors, leavening and other agents) | Antioxidants (food additives for human use) | 1 |
Most refused products from Italy
| Product | Lines | Share |
|---|---|---|
| Spaghetti | 248 | 17.2% |
| Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. | 195 | 13.5% |
| Macaroni enriched | 63 | 4.4% |
| Olives, green, (pit fruit) | 56 | 3.9% |
| Pistachio, spread | 48 | 3.3% |
| Tomatoes (fruit used as vegetable) | 45 | 3.1% |
| Chewing gum (without chocolate) | 40 | 2.8% |
| Olive oil, refined, single ingredient | 27 | 1.9% |
| Citrus flavored imitation fruit, jam, jelly, preserves, marmalade, butter or candied | 25 | 1.7% |
| Vitamin, n.e.c. | 23 | 1.6% |
FDA import alerts that list Italy firms
| Alert | Covers | Red | Green |
|---|---|---|---|
| 45-02 | Foods with illegal or undeclared colors | 31 | |
| 99-08 | Processed human and animal foods: pesticides | 27 | |
| 12-10 | Cheese: microbiological contamination | 18 | |
| 99-39 | Imported foods that appear to be misbranded | 16 | |
| 99-38 | Low-acid canned/acidified foods: inadequate process control | 11 | |
| 99-37 | Low-acid canned/acidified foods without scheduled process | 8 | |
| 16-119 | Fish products from importer and processor combinations | 6 | |
| 99-19 | Food products: Salmonella | 6 | |
| 99-36 | Low-acid canned/acidified foods: process information | 5 | |
| 34-02 | Confectionery with non-nutritive components | 4 | |
| 16-120 | Seafood from processors not in compliance with HACCP | 3 | |
| 99-05 | Raw agricultural products: pesticides | 2 |
The 12 alerts with the most listings. All alerts are on the import alerts page.
Italy firms with the most FDA records
| Firm | City | FDA records |
|---|---|---|
| Forza Vitale Italia S.r.l. | Corato | 123 |
| Ciemme Alimentari S.r.l. | Barletta | 102 |
| Pharma Green S.R.L. | Falciano | 72 |
| Tesa SRL | Foligno | 61 |
| Mado Pasticcerie | Bari | 58 |
| Molino e Pastificio de Cecco S.p.A. Pescara | Ortona | 52 |
| Indaco S.p.A. | Caivano | 43 |
| Pastificio Fabianelli S.P.A. | Castiglion Fiorentino | 41 |
| Compagnia Mercantile D'Oltremare | Mercato San Severino | 34 |
| Agugiaro & Figna Molini S.p.A. | Collecchio | 32 |
Latest refusals from Italy
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Viatris Pharma SRLMilan, Italy | Vitamin d2 (calciferol) | UNAPPROVED | Source | |
| Indaco S.p.A.Caivano, Italy | Chewing gum (without chocolate) | UNSAFE COLCOLOR LBLG | Source | |
| Savini Tartufi SRLMontanelli Palaia, Italy | Mushrooms and other fungi products, broken or kibbled, n.e.c | NO PROCESS | Source | |
| Prodotti Rubicone srlForlimpopoli, Italy | Ice cream and related products, n.e.c | UNSAFE COLCOLOR LBLG | Source | |
| Prodotti Rubicone srlForlimpopoli, Italy | Ice cream and related products, n.e.c | UNSAFE COLCOLOR LBLG | Source | |
| Prodotti Rubicone srlForlimpopoli, Italy | Ice cream and related products, n.e.c | UNSAFE COLCOLOR LBLG | Source | |
| Prodotti Rubicone srlForlimpopoli, Italy | Ice cream and related products, n.e.c | UNSAFE COLCOLOR LBLG | Source | |
| Prodotti Rubicone srlForlimpopoli, Italy | Ice cream and related products, n.e.c | UNSAFE COLCOLOR LBLG | Source | |
| Il Tartufo di Paolo di Emanuele Menichini & C S.A.S.Spello, Italy | Sauces, n.e.c | NO PROCESS | Source | |
| GiaguaroSarno, Italy | Tomatoes (fruit used as vegetable) | FILTHY | Source | |
| Bulgari Agostino SrlPavone del Mella, Italy | Marshmallow candy, soft, without nuts and fruit (without chocolate) | UNSAFE COLLIST INGRELACKS N/C+3 | Source | |
| Mid Dolciaria SRLBelpasso, Italy | Pastry (eclairs, cream puffs) custard or cream filled | UNSAFE COLCOLOR LBLG | Source | |
| Trivelli Tartufi, SrlRoccafluvione, Italy | Sauces, n.e.c | INADPRCCTL | Source | |
| MediControguerra, Italy | Mixed fishery/seafood products, n.e.c | FALSE | Source | |
| MediControguerra, Italy | Mussels | FALSE | Source | |
| GiaguaroSarno, Italy | Tomatoes (fruit used as vegetable) | FILTHY | Source | |
| GiaguaroSarno, Italy | Tomatoes (fruit used as vegetable) | FILTHY | Source | |
| Il Tartufo di Paolo di Emanuele Menichini & C S.A.S.Spello, Italy | Truffle, fungi products, n.e.c | NO PROCESS | Source | |
| MediControguerra, Italy | Mussels | FALSE | Source | |
| Fattoria di Petroio societete agricola a R.L.Castelnuovo Berardenga, Italy | Olive oil, refined, single ingredient | PESTICIDE | Source |
Questions about FDA refusals from Italy
- How many Italy shipments did FDA refuse in 2026?
- FDA refused 77 shipment lines from Italy in 2026 through October 8, 2026, compared with 131 in 2025 (a full year).
- Why does FDA refuse food from Italy?
- FDA records a charge code on every refused shipment line. For Italy the most frequent are NUTRIT LBL (nutrition information missing from label, 365 lines), UNSAFE COL (color additive unsafe under section 721, 234 lines) and NO ENGLISH (required label information not in English, 196 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 Italy firms have the most FDA refusals?
- In SupplierRadar's records the Italy firms with the most FDA records (refusals, import alert listings and other events) are Forza Vitale Italia S.r.l. (Corato) with 123 records, Ciemme Alimentari S.r.l. (Barletta) with 102 records and PHARMA GREEN S.R.L. (Falciano) with 72 records. Each firm's page lists every record with its FDA source.
- Which FDA import alerts list Italy firms?
- As of October 26, 2026, 19 FDA import alerts list at least one firm in Italy. The alerts with the most Italy listings are Import Alert 45-02 (31 firms), Import Alert 99-08 (27 firms) and Import Alert 12-10 (18 firms).
- How many Italy firms are on an FDA import alert red list?
- As of October 26, 2026, 141 Italy firms are on the red list of at least one FDA import alert in SupplierRadar's records, and 141 firms are on any list.
All Italy suppliers with FDA records (184)
- Indaco S.p.A.Caivano
- Prodotti Rubicone srlForlimpopoli
- Conserve Italia Societa Cooperativa AgricolaCodigoro
- Il Tartufo di Paolo di Emanuele Menichini & C S.A.S.Spello
- GiaguaroSarno
- Mid Dolciaria SRLBelpasso
- Trivelli Tartufi, SrlRoccafluvione
- Fattoria di Petroio societete agricola a R.L.Castelnuovo Berardenga
- Calugi, SRLCastelfiorentino
- Demar Di Pesare F. & C. SRLCesena
- Campo d"Oro S.r.l.Sciacca
- Oleificio Pasquinoni S.N.C.Cerasolo Ausa Di Coriano
- Skane KonfetyrerNaples
- Mado PasticcerieBari
- Peyrano Torino SRLTurin
- Sarda Affumicati SRL Sardaf SRLCagliari
- Tartufi Bianconi, S.R.L.Citta' Di Castello
- Conserve Italia ArlSan Lazzaro di Savena
- I Dolci Sapori dell'Etna S.r.l.Bronte
- Armatore SRLCetara
- Flott S.P.A.Bagheria
- Rosso di Mazara S.R.L.Mazara Del Vallo
- Irc William di Carlo SRLSulmona
- Dais S.p.A.Belpasso
- Agrozootecnica Marchesa srlGrazzanise
- ParmalatCollecchio
- Cap Cooperativa Allevatori Putignano Soc. CoopPutignano
- Ferrero -SpaAlba
- A&F 1931 SRLVilla San Giovanni
- Pescaradolc SrlSpoltore
- Antichi Sapori Umbri di Antinori Petrini Monica & C. S.A.S. Limited CompanySpoleto
- Trivelli TartufiRoccafluvione
- Luigi Zaini S.p.AMilan
- Sweet Cream S.R.L.S.Bellizzi
- Dulac Farmaceutici 1982 SRLTurin
- Drop ItaliaPrato
- Agr.E.S. SRLCarini
- Dulac FarmaceuticiRivoli
- Agugiaro & Figna Molini S.p.A.Collecchio
- Sanpellegrino S.p.A.San Pellegrino Terme
- Cafe Do Brasil SpaMelito Di Napoli
- Colussi SpaMilan
- Pastificio Di Bari TARALL'ORO S.r.lSammichele Di Bari
- Pastificio Gallo Natale F. LLI SRLMazara Del Vallo
- Compagnia Mercantile D'OltremareMercato San Severino
- Pastificio Riscossa - F.ill Mastromauro spaCorato
- Citozeatec SRLPeschiera Borromeo
- Giovanna BeccariaMessina
- Cerratina ServiziLanciano
- Azienda Agricola Chiavaroli GiovanniPianella
- Sorelle Nurzia SRLL'Aquila
- Madama Oliva SrlCarsoli
- Pastificio Fabianelli S.P.A.Castiglion Fiorentino
- Merlini S.r.l.Sommacampagna
- Attina & Forti S.R.L.Villa San Giovanni
- Ciemme Alimentari S.r.l.Barletta
- Soc. Agr. Artemide SncPietradefusi
- Optima Srl con unico socioSan Clemente
- Fratelli Polli S.p.A.Monsummano Terme
- Flli Polli S.p.A.Lozzo Atestino
- A Ricchigia S.R.LBronte
- F.lli DE CECCO di FILIPPO FARA SAN MARTINO S.P.AFara San Martino
- Bassi S.p.A.Marano Ticino
- Azienda Agroalimentare, GiovanniSanto Stefano Quisquina
- Campisi Salvatore SRLPachino
- Clock Tower Cafe S.N.C.Cianciana
- Asiago Food SpaVeggiano
- Ricocrem CozzoCarini
- Cooperativa Agricola IL FortetoVicchio
- Fratelli Nappi 2 s.r.l.San Gennaro Vesuviano
- Assegnatari Associati Arborea SOC. COOP. AGR.P.A.Arborea
- Molino e Pastificio de Cecco S.p.A. PescaraOrtona
- Le Conserve Daune SRLCerignola
- Ciaccadi' SRLRome
- Delfino Battista SRLCetara
- S.A.M srlMartina Franca
- Colussi SpaFossano
- EPO S.r.l.Milan
- CorexBattipaglia
- Lodato Gennaro & C S.p.A.Castel San Giorgio
- Tesa SRLFoligno
- Forza Vitale Italia S.r.l.Corato
- Appetais Italia S.p.A.Genoa
- Slitti Luciani e C. SncMonsummano Terme
- Olive Petruzzelli SRLCerignola
- Delfino Battista SRLMontecorvino Pugliano
- Natura And SoleSan Servo (Fg)
- Cora Formiaggi di Gianni Cora s.a.sMonesiglio
- Lindt & Sprungli SpALuserna San Giovanni
- Frantoio Bonamini SRLIllasi
- Oleifici Asaro Dal 1916 S.R.L.Partanna
- Riseria Modenese SRLCarpi
- Capri RisoCarpi
- Rummo Lenta Lavorazione SpaBenevento
- Si Invernizzi S.R.LTrecate
- Di Vita S.p.ACarmagnola
- I.D.B. Industria Dolciaria BelpassoBelpasso
- Caseificio Dell'Alta Langa S.R.LBosia
- Apulia Distribuzione SRLRUTIGLIANO
- Norda SpaLecco
- Masiello FoodsCerignola
- Pharma Green S.R.L.Falciano
- Azienda AgricolaGreve in Chiant
- E Pharma Trento SpaTrento
- Azienda Agricola D'Assisi di FraPonte
- Azienda Agricola D'AssisiCasalduni
- Biolevante s.r.l.Andria
- Mocine Societa' Cooperativa AgricolaAsciano
- Az. Agr. La GallinellaVelezzo Lomellina
- Olio Roi di Boeri FrancoBadalucco
- Brunella Food Industry S.r.l.San Marzano Sul Sarno
- Cinquina InternationalLanciano
- Acetaia MalpighiModena
- Mazzone Extravergine De CampanaleRuvo di Puglia
- Azienda Agricola Erga Bio di Damiano ErmicidaBadolato
- Antica Dolceria Bonajuto di RutaModica
- OLEIFICIO POLLA NICOLO CompanyLoano
- La Fabbrica Della Pasta Di Gragnano S.R.L.Gragnano
- Coopearativa Pescatori e Molluschicoltori S.c.r.l.Cabras
- Prodal SRLSan Dona' Di Piave
- Luigi Zaini S.p.A.Senago
- Giordano SRLStriano
- Si Cheese di Grifa IlariaGiovanni Rotondo
- Euromar di Silvano Carso PietroSan Benedetto Del Tronto
- Dolciaria Luigia Snc Di Baiocchi Natale & C.Bellaria-Igea Marina
- Amarischia S.p.A.Caivano
- Azienda Agricola ViginTreiso
- Cascina la GhersaMoasca
- Spumador SpaFelegarafelegara
- Spumador SpACadorago
- Rebecchi Fratelli Valtrebbia S.P.A.Rivergaro
- Caseificio Sociale RinascenteBagnolo Mella
- Oleificio Borelli SpaPontedassio
- Bio Conserve S.R.L.Cerignola
- Charlie Brown di Rutigliano & Figli S.r.l.Binetto
- Cons. Pescatori Goro-Soc. Coop. Va A.R.L.Goro
- Conserviera Adriatica S.p.A.Offida
- Dalce Srl (Ltd)Talamona
- De Langlade & GrancelliGenoa
- Gatti RobertoLatina
- Logro S.P.A. Industria ConservieraPaese
- Morra G Figli S A SAlba
- PucciLugo
- Puglia Conserve SrlModugno
- The St Erasmo Exp Pres S P APagani
- Tigullio S.P.A.Milan
- Velleca Olive S.N.C.Naples
- Velleca Salvatore S.N.C.Naples
- Azienda Agricola Angelo FerranteSalerno
- Acqua Minerale San Benedetto S.p.A.Scorze'
- Epo SrlBuccinasco
- Canti SRL Degl'Innocenti GiancarloArezzo
- Ellebi S.A.S. Di Bifulco Michele & C.San Paolo Bel Sito
- Vincenzo Di Iorio s.a.s.Pietradefusi
- Fattorie Chiarappa S.R.L.5 Conversano
- Erbital Di Cavallo MarcoTricerro
- SOLKY Affumicati e Salati di Fois Fernando AntiocoSant'Antioco
- Az. Agr. Calcare SrlNoicattaro
- Cooperative Formaggi e SardegnaMacomer
- Furio GiuseppeMola Di Bari
- Coalma SpaPalermo
- Euricom S.P.AValle Lomellina
- Cisa S.R.L.Rovereto
- Caseificio Pezzana 2 S.R.L.Frossasco
- Caseificio Pezzana S.R.L.Turin
- Caseificio VallicinoGalliate
- Caseificio Voglia di latte srlBisceglie
- CLIN Coop Produttori Latte Indenne Della Provincia Di NovaraCampriano
- Cooperativa Allevatori VillanovesiVillanova Monteleone
- Cooperative Allevatori Salernitani A R LBattipaglia
- Di Iorio S.p.A.Frosolone
- Industria Casearia CentralCagliaricas
- Lago MonotiTrevadone
- Mucci Giovanni SrlTrani
- Perugina Sede CoperativaMilan
- S P A Edigio GalbaniMelzo
- Tiger Trading SrlVerona
- Bertagni Industrie Alimentari SpaBologna
- Eureka S.R.L.Acerra
- Eurofruit S.r.l.Avella
- European Rice CompanyVercelli
- Felice BonardiAlba
- Nestle' Italiana SpaMilan
- Webb JamesLeghorn
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Buying from Italy?
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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.