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FDA Inspections, Warning Letters and Import Refusals: India

FDA has recorded 4,185 inspections of firms in India, 374 of them (8.9%) classified OAI. It has issued 236 warning letters to firms there and refused 57,380 import shipments. 1,504 firms in India 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.

India: FDA inspections per year 2017: 254 inspections25420172018: 399 inspections39920182019: 455 inspections45520192020: 115 inspections11520202021: 33 inspections3320212022: 156 inspections15620222023: 302 inspections30220232024: 407 inspections40720242025: 366 inspections36620252026: 174 inspections1742026
YearInspectionsOAIOAI shareWarning lettersImport refusals
2026174137.5%214,969
2025366369.8%225,736
2024407266.4%164,391
2023302278.9%162,479
20221562113.5%61,762
202133721.2%11,923
2020115108.7%201,944
2019455429.2%241,760
2018399235.8%111,935
20172543212.6%202,001

Latest OAI inspections

DateFacilityProduct type
Aug 12, 2026Steril-Gene Life Sciences Private LtdDrugs
Jun 6, 2026PRITAM INTERNATIONAL PRIVATE LIMITEDDrugs
May 15, 2026Mylan Laboratories LimitedDrugs
Apr 17, 2026Shoolin Pharma Chem LLPDrugs
Apr 17, 2026USV Private LimitedDrugs
Feb 27, 2026Reliance Life Sciences Private LimitedDrugs
Feb 13, 2026Almon Healthcare Private LimitedDrugs
Feb 9, 2026BioMylz Pvt. Ltd.Drugs
Feb 6, 2026Eugia Pharma Specialities LimitedDrugs
Feb 6, 2026Auriga Research Private LimitedDrugs
Jan 27, 2026Centrient Pharmaceuticals India Private LimitedDrugs
Jan 23, 2026Shimoga ChemicalsDrugs
Jan 16, 2026Dabur India LimitedDrugs
Dec 12, 2025SMS Pharmaceuticals LimitedDrugs
Dec 10, 2025Wizcure Pharmaa Private LimitedDrugs
Dec 4, 2025Alchymars ICM SM Private LimitedDrugs
Nov 27, 2025Gland Chemicals Private LimitedDrugs
Nov 19, 2025Vanity VisionFood/Cosmetics
Nov 14, 2025EUGIA Pharma Specialities LimitedDrugs
Oct 31, 2025Batra EnterprisesFood/Cosmetics
Sep 26, 2025Abryl Laboratories Private LimitedDrugs
Sep 19, 2025Inventaa Chemicals Private LimitedDrugs
Sep 18, 2025Immacule Lifesciences Private LimitedVeterinary
Sep 16, 2025Intas Pharmaceuticals Ltd.Drugs
Sep 12, 2025Flowchem Pharma Private LimitedDrugs

Showing the latest 25 of 374.

Latest warning letters

DateFirmProduct typeFDA center
Aug 18, 2026Reliance Life Sciences Private LimitedDrugsCDER
Aug 18, 2026Shoolin Pharma Chem LLPDrugsCDER
Aug 13, 2026EUGIA Pharma Specialities LimitedDrugsCDER
Aug 12, 2026Auriga Research Private LimitedDrugsCDER
Jul 24, 2026Dabur India LimitedDrugsCDER
Jul 13, 2026Almon Healthcare Private LimitedDrugsCDER
Jul 13, 2026BioMylz Pvt. Ltd.DrugsCDER
Jul 13, 2026Shimoga ChemicalsDrugsCDER
Jun 24, 2026Wizcure Pharmaa Private LimitedDrugsCDER
Jun 17, 2026GREAT INDIA OVERSEAS PVT LTDDrugsCDER
Jun 17, 2026Indiangoods.ShopDrugsCDER
Jun 2, 2026Gopaldas Visram & Company Ltd.DrugsCDER
Jun 2, 2026UMENDRA LIFE SCIENCES PRIVATE LIMITEDDrugsCDER
Jun 2, 2026Zydus Lifesciences LimitedDrugsCDER
May 21, 2026Alchymars ICM SM Private LimitedDrugsCDER
Mar 30, 2026Intas Pharmaceuticals Ltd.DrugsCDER
Mar 12, 2026Patcos Cosmetics (India) Private LimitedDrugsCDER
Mar 11, 2026Flowchem Pharma Private LimitedDrugsCDER
Mar 9, 2026Vedic Lifesciences Pvt LtdDrugsCDER
Mar 3, 2026Megsan Labs Private LimitedDrugsCDER
Jan 30, 2026Cohance Lifesciences LimitedDrugsCDER
Dec 23, 2025Chemspec Chemicals Private LimitedDrugsCDER
Dec 22, 2025P. Damodara Kumaran, M.D.DrugsCDER
Dec 11, 2025Palamur Biosciences Private LimitedDevicesCDRH
Nov 17, 2025HANDELNINE GLOBAL LLPDrugsCDER

Showing the latest 25 of 236.

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

Latest import refusals

DateFirmProduct category
Oct 22, 2026BLUE CROSS LABARATARIS LTDDrugs and Biologics
Oct 22, 2026Glenmark Pharmaceuticals LimitedDrugs and Biologics
Oct 22, 2026ERIS THERAPEUTICS LTDDrugs and Biologics
Oct 22, 2026RADIENT PHARMADrugs and Biologics
Oct 22, 2026Dholakia Tobacco Pvt LtdTobacco Products
Oct 22, 2026DHOLAKIATobacco Products
Oct 22, 2026BIPCA LABORATORIESDrugs and Biologics
Oct 22, 2026BIPCA LABORATORIESDrugs and Biologics
Oct 22, 2026BIPCA LABORATORIESDrugs and Biologics
Oct 22, 2026LIVKON PHARMACEUTICALS PRIVATE LHuman Foods
Oct 22, 2026Dholakia Tobacco Pvt LtdTobacco Products
Oct 22, 2026Dholakia Tobacco Pvt LtdTobacco Products
Oct 22, 2026Dholakia Tobacco Pvt LtdTobacco Products
Oct 22, 2026Dholakia Tobacco Pvt LtdTobacco Products
Oct 22, 2026Dholakia Tobacco Pvt LtdTobacco Products
Oct 22, 2026Dholakia Tobacco Pvt LtdTobacco Products
Oct 22, 2026Dholakia Tobacco Pvt LtdTobacco Products
Oct 22, 2026Dholakia Tobacco Pvt LtdTobacco Products
Oct 21, 2026PFIZER LIMITEDDrugs and Biologics
Oct 21, 2026WAXWING PHARMADrugs and Biologics
Oct 21, 2026NEW KASHMIR TRADING COMPANYDrugs and Biologics
Oct 21, 2026HANDA HEALTHCARE CENTERDrugs and Biologics
Oct 21, 2026TRI PUSHP PHARMADrugs and Biologics
Oct 21, 2026SUPERDAY MARKETING PVT LTDDrugs and Biologics
Oct 21, 2026CIPLA LTDDrugs and Biologics

Showing the latest 25 of 57,380.

See every import refusal from India.

Firms on FDA import alerts

PublishedFirmImport alertList
Nov 10, 2026Al-Zoya Overseas, Pvt. Ltd.71-04red
Nov 6, 2026AAVISHKAR ORAL STRIPS PRIVATE LIMITED66-41red
Nov 6, 2026Aavishkar Oral Strips Pvt., Ltd.66-41red
Nov 6, 2026Batra Enterprises99-39red
Nov 6, 2026Naik Oceanic Exports Private Limited16-35green
Nov 6, 2026Nutritionalab Private Limited66-41red
Nov 4, 2026Kumar Agro Foods99-45red
Nov 4, 2026NESTLE INDIA LIMITED99-45red
Oct 27, 2026COHESION BIOTEC PRIVATE LIMITED66-40red
Oct 20, 2026Euroasias99-19red
Oct 20, 2026EUROASIAS INGREDIENTS PVT LTD99-19red
Oct 20, 2026Geo Fresh Organic Pvt Ltd99-19red
Oct 13, 2026Nestle India Limited99-22red
Oct 13, 2026SHRIYAN HEALTHCARE99-34red
Oct 6, 2026SINGAL INFINITY LLP99-19red
Oct 1, 2026GAYATRI MARINE PRODUCTS16-35green
Sep 23, 2026Horster Biotek Private Limited66-79red
Sep 22, 2026Citroen Commodities99-08red
Sep 22, 2026Nector Foods Pvt Ltd45-02red
Sep 16, 2026Harish Bakers And Confectioners Private Limited99-19red
Sep 15, 2026CANVAS VENTURES99-08red
Sep 15, 2026CANVAS VENTURES99-08red
Sep 14, 2026BASILLIA ORGANICS PVT LTD99-19red
Sep 3, 2026BIOPHARMA ASSOCIATES99-34red
Sep 3, 2026GHAN MARINE PRODUCTS16-35green

Showing the latest 25 of 1,504.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Sun Pharmaceutical Industries LtdVadodara120Jul 24, 2026
Sun Pharmaceutical Industries Ltd.Halol125Jun 13, 2025
Cipla LimitedSalcette122Jun 21, 2024
Aurobindo Pharma LtdMedchal121Jul 21, 2023
Strides Pharma Science LimitedBangalore110May 20, 2026
Sitec Labs LimitedNavi Mumbai110Apr 23, 2026
Biocon Biologics LimitedBengaluru111Jul 26, 2024
Intas Pharmaceuticals LimitedAhmedabad110Jul 12, 2024
Somerset Therapeutics Private LimitedBengaluru104Feb 21, 2025
Zydus Lifesciences LimitedAhmedabad103Aug 5, 2022
Emcure Pharmaceuticals LimitedPune103Feb 20, 2019
OneSource Specialty Pharma LimitedBengaluru91Jun 30, 2026
Mylan Laboratories LimitedNashik92May 15, 2026
Apitoria Pharma Private LimitedSangareddy90Dec 12, 2025
Lupin LimitedVerna91Nov 21, 2025

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.