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FDA Inspections, Warning Letters and Import Refusals: Sri Lanka

FDA has recorded 141 inspections of firms in Sri Lanka, 6 of them (4.3%) classified OAI. It has issued 2 warning letters to firms there and refused 1,402 import shipments. 43 firms in Sri Lanka 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.

All countries · Check one supplier with the free FDA compliance check.

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.

Sri Lanka: FDA inspections per year 2017: 1 inspections120172018: 2 inspections220182019: 9 inspections920192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 34 inspections3420232024: 22 inspections2220242025: 4 inspections420252026: 5 inspections52026
YearInspectionsOAIOAI shareWarning lettersImport refusals
2026500.0%052
2025400.0%036
20242200.0%015
20233400.0%025
202200016
202100041
202000020
2019900.0%051
2018200.0%070
2017100.0%050

Latest OAI inspections

DateFacilityProduct type
Jun 17, 2015Tropic Fishery Pvt. Ltd.Food/Cosmetics
Jun 10, 2015Target Agriculture (Pvt) Ltd.Food/Cosmetics
Jun 9, 2015Foreconns CanneriesFood/Cosmetics
Jun 5, 2015Foreconns CanneriesFood/Cosmetics
Dec 18, 2013Pan-Am Foods (Pvt) Ltd.Food/Cosmetics
Dec 10, 2013AMK Food Export (Pvt) LtdFood/Cosmetics

Latest warning letters

DateFirmProduct typeFDA center
Dec 10, 2015Target Agriculture (Pvt) Ltd.Food/CosmeticsCFSAN
May 15, 2014AMK Food Export (Pvt) LtdFood/CosmeticsCFSAN

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

Latest import refusals

DateFirmProduct category
Oct 21, 2026Dru Era (Pvt) LtdHuman Foods
Oct 21, 2026Dru Era (Pvt) LtdHuman Foods
Oct 20, 2026M M M SHIRAFDrugs and Biologics
Oct 20, 2026M M M SHIRAFDrugs and Biologics
Oct 20, 2026M M M SHIRAFDrugs and Biologics
Oct 20, 2026M M M SHIRAFDrugs and Biologics
Oct 20, 2026M M M SHIRAFDrugs and Biologics
Oct 20, 2026M M M SHIRAFDrugs and Biologics
Oct 19, 2026Dru Era (Pvt) LtdHuman Foods
Oct 19, 2026Dru Era (Pvt) LtdHuman Foods
Oct 19, 2026Dru Era (Pvt) LtdHuman Foods
Oct 8, 2026Dru Era (Pvt) LtdHuman Foods
Oct 8, 2026Dru Era (Pvt) LtdHuman Foods
Oct 8, 2026Dru Era (Pvt) LtdHuman Foods
Oct 6, 2026Dru Era (Pvt) LtdHuman Foods
Oct 6, 2026Dru Era (Pvt) LtdHuman Foods
Oct 2, 2026Dru Era (Pvt) LtdHuman Foods
Oct 2, 2026Dru Era (Pvt) LtdHuman Foods
Oct 2, 2026Dru Era (Pvt) LtdHuman Foods
Sep 24, 2026Dru Era (Pvt) LtdHuman Foods
Sep 22, 2026Dru Era (Pvt) LtdHuman Foods
Sep 22, 2026Dru Era (Pvt) LtdHuman Foods
Sep 18, 2026Dru Era (Pvt) LtdDrugs and Biologics
Sep 16, 2026Dru Era (Pvt) LtdHuman Foods
Sep 14, 2026Dru Era (Pvt) LtdHuman Foods

Showing the latest 25 of 1,402.

Firms on FDA import alerts

PublishedFirmImport alertList
Feb 13, 2026E-SILK ROUTE VENTURES (PVT) LTD.99-42red
Feb 13, 2026E-SILK ROUTE VENTURES PVT LTD99-42red
Jan 22, 2026Imperial Spices Pvt. Ltd.99-19red
Jan 22, 2026IMPERIAL SPICES (PVT) LTD99-19red
Nov 3, 2025Eswaran Brothers Exports (PVT) Ltd99-19red
Aug 31, 2023Nestle Lanka PLC99-39red
Jun 23, 2023AMK Food Export (Pvt) Ltd99-08red
Apr 12, 2021Wijaya Products (Pvt) Ltd.99-19red
Mar 30, 2020Lanka Canneries (Pvt) Ltd.99-38red
Dec 13, 2019Taprobane Seafood (PVT) LTD.16-105red
Oct 19, 2018GLOBAL SEA FOODS (Pvt) Ltd16-105red
Oct 19, 2018GLOBAL SEA FOODS PVT LTD - UNIT 216-105red
May 17, 2018SRS FRUIT N SPICES (PVT) LTD99-35red
May 17, 2018SRS FRUIT N SPICES (PVT) LTD99-35red
Apr 20, 2018SRS FRUIT N SPICES (PVT) LTD23-12red
Apr 20, 2018SRS FRUIT N SPICES (PVT) LTD23-12red
Jun 13, 2016ARUNALU PRODUCTS99-39red
May 20, 2016ARUNALU PRODUCTS16-74red
Apr 18, 2016Dru Era (Pvt) Ltd66-41red
Feb 19, 2016Northwest Fishery (Pvt) Ltd16-125green
Dec 9, 2015Foreconns Canneries99-37red
Nov 27, 2015Foreconns Canneries16-120red
Jun 5, 2014Pan-Am Foods (Pvt) Ltd.99-38red
Apr 4, 2014Pan-Am Foods (Pvt) Ltd.16-120red
Oct 10, 2013Taprobane Seafood (PVT) LTD.16-81red

Showing the latest 25 of 43.

Most-inspected facilities

FacilityCityInspectionsOAILatest
SDS Spices (Pvt) LtdGalle District20Aug 29, 2024
Wichy Plantation Company (Pvt) LtdWariyapola20Aug 23, 2024
Sierra Rice Products Pvt LtdEmbilipitiya20Aug 21, 2024
EOAS INTERNATIONAL (PRIVATE) LIMITEDGonapola Junction20Sep 21, 2023
HDDES EXTRACTS (PVT) LTDKalutara20Sep 19, 2023
CBL Natural Foods (Pvt.) Ltd.Minuwangoda20Sep 11, 2023
Greenfield Bio Plantations (Pvt) Ltd.Colombo-0220Sep 7, 2023
S.A. Silva & Sons Lanka (Pvt) Ltd.Mirigama20Sep 5, 2023
L.B.SPICES TRADING (PVT) LTDAmbalangoda20Aug 22, 2023
Waguruwela Oil Mills (Pvt) Ltd.Welpalla20Jun 12, 2023
Alpex Marine (Pvt) Ltd.Wattala20Oct 24, 2019
Taprobane Seafood (PVT) LTD.Dankotuwa20Oct 18, 2019
International Commodity Exports Private LimitedGiriulla20Oct 8, 2019
Nestle Lanka PLCGonawila20Jul 26, 2017
Target Agriculture (Pvt) Ltd.Weligama21Aug 19, 2016

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.