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FDA Inspections, Warning Letters and Import Refusals: Dominican Republic

FDA has recorded 0 inspections of firms in Dominican Republic, 0 of them (0%) classified OAI. It has issued 12 warning letters to firms there and refused 6,415 import shipments. 0 firms in Dominican Republic are named on FDA import alerts.

OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after an inspection. A warning letter is FDA's formal notice of significant violations. An import refusal is a shipment FDA refused entry to the United States.

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By year

The last 10 calendar years (2017 to 2026, 2026 so far). FDA adds classified inspections and posts actions months after they happen, so recent years can still grow.

Dominican Republic: FDA import refusals per year 2017: 89 import refusals8920172018: 105 import refusals10520182019: 161 import refusals16120192020: 129 import refusals12920202021: 71 import refusals7120212022: 113 import refusals11320222023: 136 import refusals13620232024: 302 import refusals30220242025: 100 import refusals10020252026: 103 import refusals1032026
YearInspectionsOAIOAI shareWarning lettersImport refusals
2026001103
2025000100
2024001302
2023001136
2022000113
202100171
2020000129
2019000161
2018001105
201700089

Latest OAI inspections

No OAI inspections are recorded for firms in Dominican Republic.

Latest warning letters

DateFirmProduct typeFDA center
Jun 2, 2026Laboratorios Dr. Collado S.A.DrugsCDER
Jun 21, 2024Laboratorio Magnachem International, S.A.DrugsCDER
Jul 10, 2023Chean Industries Dominicana S.R.L.Food/CosmeticsCFSAN
Sep 22, 2021Ardil Comercial S.R.L.DrugsCDER
Mar 9, 2018Laboratorios Labocont Industrial SRLDrugsCDER
Sep 14, 2015REMINGTON MEDICAL, S.A.DevicesCDRH
Oct 16, 2014Alopecil Corporation, S.R.L.Food/CosmeticsCFSAN
Nov 25, 2013Fresh Directions Dominicana S.A.Food/CosmeticsCFSAN
Jul 1, 2013Sabila, SRLFood/CosmeticsCFSAN
Jun 6, 2013Constanza Agroindustrial SRLFood/CosmeticsCFSAN
Jul 20, 2012Arriol International Corp.DevicesCDRH
Nov 17, 2009New Horizons LTDDrugsCDER

Search every letter by company with the FDA warning letter search.

Latest import refusals

DateFirmProduct category
Oct 21, 2026EXPORTADORA SERAFINO, C POR A.Human Foods
Oct 21, 2026NATURAL FARM SRLHuman Foods
Oct 20, 2026Boe Dominicana SRLCosmetics
Oct 20, 2026Boe Dominicana SRLCosmetics
Oct 20, 2026Boe Dominicana SRLCosmetics
Oct 20, 2026Boe Dominicana SRLCosmetics
Oct 20, 2026Boe Dominicana SRLCosmetics
Oct 7, 2026JGL TRADING EXPORT RDHuman Foods
Oct 1, 2026EXPORTADORA SERAFINO, C POR A.Human Foods
Oct 1, 2026Rossland Agricultural Products, LTDHuman Foods
Sep 17, 2026EXPORTADORA SERAFINO, C POR A.Human Foods
Aug 11, 2026EXPORTADORA SERAFINO, C POR A.Human Foods
Jul 30, 2026EXPORTADORA SERAFINO, C POR A.Human Foods
Jul 30, 2026EXPORTADORA SERAFINO, C POR A.Human Foods
Jul 7, 2026Laboratorios Roldan S.A.Cosmetics
Jul 7, 2026Laboratorios Roldan S.A.Cosmetics
Jul 7, 2026Laboratorios Roldan S.A.Cosmetics
Jul 7, 2026Laboratorios Roldan S.A.Cosmetics
Jul 7, 2026Laboratorios Roldan S.A.Cosmetics
Jul 7, 2026Laboratorios Roldan S.A.Cosmetics
Jul 7, 2026Laboratorios Roldan S.A.Cosmetics
Jul 7, 2026Laboratorios Roldan S.A.Cosmetics
Jul 7, 2026Laboratorios Roldan S.A.Cosmetics
Jul 7, 2026Baxter Healthcare S.A.Devices
Jul 7, 2026Baxter Healthcare S.A.Devices

Showing the latest 25 of 6,415.

See every import refusal from Dominican Republic.

Firms on FDA import alerts

No firms in Dominican Republic are recorded on FDA import alerts.

Most-inspected facilities

No inspected facilities are recorded in Dominican Republic.

See each facility's Form 483 observations with the FDA 483 search.

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.