FDA Inspections, Warning Letters and Import Refusals: Bangladesh
FDA has recorded 35 inspections of firms in Bangladesh, 2 of them (5.7%) classified OAI. It has issued 0 warning letters to firms there and refused 2,698 import shipments. 140 firms in Bangladesh 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.
Bangladesh: FDA inspections per year
2017: 0 inspections 0 2017 2018: 0 inspections 0 2018 2019: 0 inspections 0 2019 2020: 2 inspections 2 2020 2021: 0 inspections 0 2021 2022: 0 inspections 0 2022 2023: 2 inspections 2 2023 2024: 0 inspections 0 2024 2025: 0 inspections 0 2025 2026: 0 inspections 0 2026
Year Inspections OAI OAI share Warning letters Import refusals
2026 0 0 0 185
2025 0 0 0 122
2024 0 0 0 76
2023 2 0 0.0% 0 76
2022 0 0 0 68
2021 0 0 0 132
2020 2 0 0.0% 0 48
2019 0 0 0 56
2018 0 0 0 74
2017 0 0 0 157
Latest warning letters
No warning letters are recorded for firms in Bangladesh.
Search every letter by company with the FDA warning letter search .
Latest import refusals
Date Firm Product category
Oct 22, 2026 MASHUD FISH PROCESSING & ICE COMPLEX, UNIT-2 Human Foods
Oct 8, 2026 PRAISE PHARMA Drugs and Biologics
Oct 2, 2026 AZEEN AGRO FOOD Human Foods
Sep 29, 2026 Naz's Agro Products Human Foods
Sep 28, 2026 BEACON PHARMACEUTICALS LIMITED Drugs and Biologics
Sep 24, 2026 TANVEER FOOD LIMITED Human Foods
Sep 21, 2026 NESTLE BANGLADESH, LTD. Human Foods
Sep 21, 2026 NESTLE BANGLADESH, LTD. Human Foods
Sep 14, 2026 The ACME Laboratories Ltd. Drugs and Biologics
Sep 11, 2026 BEXIMCO PHARMACEUTICALS LIMITED Drugs and Biologics
Aug 20, 2026 Renata Limited Drugs and Biologics
Aug 20, 2026 DELTA PHARMA Drugs and Biologics
Aug 20, 2026 ACI FOODS LTD Drugs and Biologics
Aug 20, 2026 Renata Limited Drugs and Biologics
Aug 20, 2026 ACI FOODS LTD Drugs and Biologics
Aug 17, 2026 PRAN AGRO LTD Human Foods
Aug 7, 2026 PRAN AGRO LTD Human Foods
Aug 3, 2026 Incepta Pharmaceuticals Ltd Devices
Jul 22, 2026 Danish Foods Ltd. Human Foods
Jul 22, 2026 Danish Foods Ltd. Human Foods
Jul 20, 2026 MASHUD FISH PROCESSING & ICE COMPLEX, UNIT-2 Human Foods
Jul 20, 2026 MASHUD FISH PROCESSING & ICE COMPLEX, UNIT-2 Human Foods
Jul 15, 2026 TM CONSUMER PRODUCT Human Foods
Jul 2, 2026 AG AGRO FOODS LIMITED Human Foods
Jul 2, 2026 PRAN Agro Ltd. Human Foods
Showing the latest 25 of 2,698.
Firms on FDA import alerts
Published Firm Import alert List
Jul 6, 2026 AG AGRO FOODS LIMITED 99-08 red
Jun 4, 2026 Habiganj Agro Limited 23-14 red
Jun 4, 2026 PRAN AGRO LTD 23-14 red
Jun 2, 2026 Naz's Agro Products 45-02 red
Apr 16, 2026 Organic Shrimps Export Ltd. 16-129 red
Dec 18, 2025 MASHUD FISH PROCESSING & ICE COMPLEX, UNIT-2 16-119 red
Nov 3, 2025 IFAD Multi Products Ltd 99-08 red
Aug 6, 2025 OVIJAT FOOD AND BEVERAGE INDUSTRIES LTD 99-08 red
Aug 6, 2025 OVIJAT FOOD & BEVERAGE INDUSTRIES LTD 99-08 red
Mar 31, 2025 Bizmate Trading International 71-04 red
Feb 24, 2025 Banga Millers Limited 99-19 red
Jan 23, 2025 AK PURE FOOD & BEVERAGE LIMITED 99-21 red
Sep 19, 2024 Unipex Trade Corporation 99-19 red
Jul 17, 2024 DOWLA FOODS LIMITED 99-08 red
Jun 12, 2024 Banoful & Co. 45-02 red
Jun 12, 2024 BANOFUL & CO. 99-39 red
Jun 12, 2024 BANOFUL & CO. 99-22 red
Jun 7, 2024 Unipex Trade Corporation 99-08 red
Apr 10, 2024 PRAN AGRO LTD 99-39 red
Mar 18, 2024 Kishwan Snacks Limited 99-21 red
Jan 26, 2024 PRAN Agro Ltd. 99-08 red
Jul 26, 2023 Eastern Sea Foods Ltd (Bk-05) (Office) 16-18 green
Jul 26, 2023 Fish Exports Limited 16-18 green
Jun 16, 2023 PRAN AGRO LTD 45-02 red
Jun 9, 2023 Zam Zam Cosmetic Industries Ltd 53-06 red
Showing the latest 25 of 140.
Most-inspected facilities
Facility City Inspections OAI Latest
Choudhury & Company (Bangladesh) Ltd. Chittagong 3 2 Jun 10, 2014
Beximco Pharmaceuticals Limited Gazipur 2 0 Mar 30, 2023
Square Pharmaceuticals PLC Gazipur 2 0 Jan 28, 2020
Sar & Co. Ltd Chittagong 2 0 May 9, 2012
ACI HealthCare Limited Narayanganj 1 0 Apr 6, 2023
Renata PLC (General Plant 2) Gazipur 1 0 Jan 30, 2020
Bombay Sweets & Co. Ltd. Narayanganj 1 0 Aug 9, 2015
Bombay Sweets & Co. Ltd. Dhaka 1 0 Aug 8, 2015
Eurasia Food Processing (BD) Limited Dhaka 1 0 Aug 4, 2015
M.N. International North Agarabad 1 0 Aug 2, 2015
Well Foods Ltd. Chittagong 1 0 Jun 25, 2014
IBCO Food Industries Ltd. Chittagong 1 0 Jun 24, 2014
TOHFA ENTERPRISE Dhaka 1 0 Jun 18, 2014
PRAN Dairy Ltd. Narshingdi 1 0 Jun 17, 2014
PRAN Foods Ltd Narshingdi 1 0 Jun 16, 2014
See each facility's Form 483 observations with the FDA 483 search .