Intas Pharmaceuticals Limited

FDA establishment 3003157498, Ahmedabad, India. Part of Intas Pharmaceuticals's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.

Inspections: 10
Official action indicated: 0
Last inspection ended: Jul 12, 2024
Warning letters: 1
Import refusals since 2024: 63
Import refusals 2014 to 2023: 8, first Sep 24, 2014

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

How to read this

A hatched bar is a year that is not over, so its count covers only part of the year.

22019

02021

02023

02025

02027

Most Cited at This Site

Inspections citing each reference

Inspections

10 inspections, newest first


Jul 12, 2024	Drugs · Bioresearch Monitoring	None posted	No Action Indicated (NAI)
Aug 2, 2019	Drugs · Drug Quality Assurance	14 cited references 21 CFR 211.67(b). Written procedures fail to include Written procedures for cleaning and maintenance fail to include assignment of responsibility, maintenance and cleaning schedules and description in sufficient detail of methods, equipment and materials used. 21 CFR 211.194(a)(2). Suitability of testing methods verified The suitability of all testing methods is not verified under actual conditions of use. 21 CFR 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. 21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. 21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process. 21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity. 21 CFR 211.46(c). Air recirculation of dust from production areas Air is recirculated to production areas, without adequate measures to control recirculation of dust. 21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size and suitably located to facilitate operations for its intended use and cleaning and maintenance. 21 CFR 211.42(c)(10)(iii). Air Supply Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure. 21 CFR 211.46(b). Equipment for Environmental Control Equipment for adequate control over air pressure, micro-organisms, dust, humidity and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product. 21 CFR 211.100(b). Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not recorded and justified. 21 CFR 211.160(b)(4). Establishment of calibration procedures Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed and deficiently written or followed. 21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. 21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.	Voluntary Action Indicated (VAI)
Dec 14, 2018	Drugs · Drug Quality Assurance	None posted	No Action Indicated (NAI)
Feb 17, 2017	Drugs · Drug Quality Assurance	None posted	Voluntary Action Indicated (VAI)
Jun 17, 2016	Drugs · Drug Quality Assurance	None posted	Voluntary Action Indicated (VAI)
Apr 7, 2015	Drugs · Drug Quality Assurance	None posted	Voluntary Action Indicated (VAI)
Jun 21, 2013	Drugs · Drug Quality Assurance	None posted	Voluntary Action Indicated (VAI)
May 19, 2012	Drugs · Drug Quality Assurance	None posted	Voluntary Action Indicated (VAI)
Oct 10, 2011	Drugs · Drug Quality Assurance	None posted	Voluntary Action Indicated (VAI)
Nov 13, 2009	Drugs · Drug Quality Assurance	None posted	Voluntary Action Indicated (VAI)

Warning Letters

Letters naming this establishment; each opens the letter

Data integrity, Aseptic processing, Sterility assuranceNov 21, 2023

Import Refusals

63 refused shipment lines since 2024, grouped by product and charges


BROMHEXINE HCL (EXPECTORANT)Drugs · 64HDC01	Drug made outside good manufacturing practice	Oct 9, 2026
MINOXIDIL (ANTI-HYPERTENSIVE)Drugs · 62CDY41	Drug made outside good manufacturing practice	Oct 8, 2026
CARBAMAZEPINE (ANALGESIC)Drugs · 60LCA14	Drug made outside good manufacturing practice	Sep 23, 2026
FINASTERIDE (INHIBITOR (DECARBOXYLASE))Drugs · 64UDL06	Drug made outside good manufacturing practice	Sep 18, 2026
TAMOXIFEN CITRATE (ANTI-ESTROGEN)Drugs · 61UCA05	Unapproved new drug	Aug 23, 2026
MINOXIDIL (ANTI-HYPERTENSIVE)Drugs · 62CCL41	Unapproved new drug	Aug 14, 2026
INHIBITOR N.E.C.Drugs · 64UDA99	Drug made outside good manufacturing practice	Aug 6, 20262 lines
NALTREXONE (ANTAGONIST)Drugs · 60TCA15	Drug made outside good manufacturing practice	Aug 4, 2026
CHLORZOXAZONE (RELAXANT)Drugs · 65QBA31	Drug or device not listed with FDAUnapproved new drug	Aug 3, 2026
TAMOXIFEN CITRATE (ANTI-ESTROGEN)Drugs · 61UDY05	Drug made outside good manufacturing practice	Jul 21, 2026
SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)Drugs · 61NDY78	Drug made outside good manufacturing practice	Jul 21, 2026
ESCITALOPRAM OXALATEDrugs · 61NCA83	Unapproved new drug	May 29, 2026
PACLITAXEL (ANTI-NEOPLASTIC)Drugs · 62IIP91	Drug made outside good manufacturing practice	Apr 17, 2026
TACROLIMUS (IMMUNOSUPPRESSIVE)Drugs · 64TDY08	Drug made outside good manufacturing practice	Apr 17, 2026
ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)Drugs · 61JDA08	Drug made outside good manufacturing practiceDrug or device not listed with FDAUnapproved new drug	Apr 17, 2026
FLUOXETINE (ANTI-DEPRESSANT)Drugs · 61NCA29	Drug made outside good manufacturing practice	Mar 13, 2026
RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)Drugs · 66NDY04	Drug made outside good manufacturing practice	Feb 27, 2026
BUSPIRONE HCL (TRANQUILIZER)Drugs · 66MCA09	Drug made outside good manufacturing practice	Feb 26, 2026
VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.Foods · 54YGA99	Drug made outside good manufacturing practice	Jan 18, 2026
MINOXIDIL (ANTI-HYPERTENSIVE)Drugs · 62CCY41	Drug made outside good manufacturing practice	Jan 6, 2026
CLOPIDOGREL BISULFATE (ANTI-COAGULANT)Drugs · 61LDC38	Drug made outside good manufacturing practice	Dec 29, 2025
LEVOCARNITINE (NUTRIENT/TONIC)Drugs · 65CDY07	Drug made outside good manufacturing practice	Dec 12, 2025
EMOLLIENT, LUBRICANT, N.E.C.Drugs · 64DBK99	Drug made outside good manufacturing practice	Nov 10, 2025
PANTOPRAZOLE SODIUMDrugs · 62TAA07	Drug made outside good manufacturing practiceUnapproved new drug	Oct 14, 2025
MISCELLANEOUS PATENT MEDICINES, ETC.Drugs · 66VIY99	Drug made outside good manufacturing practiceUnapproved new drug	Oct 7, 2025
MISCELLANEOUS PATENT MEDICINES, ETC.Drugs · 66VDY99	Unapproved new drug	Sep 18, 2025
ANTI-COAGULANT, N.E.C.Drugs · 61LDB99	Drug made outside good manufacturing practiceDrug or device not listed with FDAUnapproved new drug	Aug 26, 2025
SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)Drugs · 61NCY78	Unapproved new drug	Jun 16, 2025
LACTULOSE (CATHARTIC)Drugs · 63HCK10	Drug made outside good manufacturing practice	Apr 11, 2025
LITHIUM CITRATE (ANTI-DEPRESSANT)Drugs · 61NCB71	Drug made outside good manufacturing practice	Mar 26, 2025
ANTI-ECZEMATIC N.E.C.Drugs · 61SAY99	Drug made outside good manufacturing practice	Mar 20, 2025
NAPHAZOLINE HCL (ADRENERGIC)Drugs · 60CDY46	Drug made outside good manufacturing practiceUnapproved new drug	Mar 4, 2025
VALPROIC ACID (ANTI-CONVULSANT)Drugs · 61MDA41	Drug made outside good manufacturing practice	Jan 31, 2025
LACTULOSE (CATHARTIC)Drugs · 63HCL10	Unapproved new drug	Dec 17, 2024
ACETAMINOPHEN (ANALGESIC)Drugs · 60LDC01	Unapproved new drug	Dec 5, 2024
IRBESARTAN (ANTI-HYPERTENSIVE - PART II)Drugs · 62OCB37	Drug made outside good manufacturing practice	Nov 22, 2024
PANTOPRAZOLE SODIUMDrugs · 62TDB07	Unapproved new drug	Nov 14, 2024
CHLORZOXAZONE (RELAXANT)Drugs · 65QDA31	Drug made outside good manufacturing practiceDrug or device not listed with FDAUnapproved new drug	Jul 12, 2024
DICLOFENAC SODIUM (ANTI-INFLAMMATORY)Drugs · 62GDY18	Drug made outside good manufacturing practice	Jul 2, 2024
DESVENLAFAXINE SUCCINATEDrugs · 61NDC84	Drug made outside good manufacturing practice	Jun 17, 2024
OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART IIDrugs · 66NDY02	Drug made outside good manufacturing practice	Apr 9, 2024
LACTULOSE (CATHARTIC)Drugs · 63HDA10	Drug made outside good manufacturing practice	Apr 1, 2024
FINASTERIDE (INHIBITOR (DECARBOXYLASE))Drugs · 64UDA06	Drug made outside good manufacturing practice	Mar 21, 2024
METOPROLOL SUCCINATE (ANTI-HYPERTENSIVE - PART II)Drugs · 62OCY43	Drug made outside good manufacturing practice	Mar 1, 2024
HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)Drugs · 62LCA29	Drug made outside good manufacturing practice	Jan 25, 20248 lines
TACROLIMUS (IMMUNOSUPPRESSIVE)Drugs · 64TCO08	Drug made outside good manufacturing practice	Jan 19, 20245 lines
SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)Drugs · 61NCA78	Drug made outside good manufacturing practice	Jan 19, 20242 lines
ANTINEOPLASTIC, NECOther · 58DCZ99	Drug made outside good manufacturing practice	Jan 10, 20242 lines
OXYBUTYNIN CHLORIDE (ANTI-CHOLINERGIC)Drugs · 61KCB34	Drug made outside good manufacturing practice	Jan 10, 2024

Identifiers

FEI number: 3003157498
FDA firm profile: Data Dashboard
Inspection program: 7356.002, Drug Manufacturing Inspections
Company: Intas Pharmaceuticals

An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard, warning letters and enforcement reports

Jul 12, 2024

Drugs · Bioresearch Monitoring

None posted

No Action Indicated (NAI)

Aug 2, 2019

Drugs · Drug Quality Assurance

14 cited references

21 CFR 211.67(b). Written procedures fail to include Written procedures for cleaning and maintenance fail to include assignment of responsibility, maintenance and cleaning schedules and description in sufficient detail of methods, equipment and materials used.
21 CFR 211.194(a)(2). Suitability of testing methods verified The suitability of all testing methods is not verified under actual conditions of use.
21 CFR 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.46(c). Air recirculation of dust from production areas Air is recirculated to production areas, without adequate measures to control recirculation of dust.
21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size and suitably located to facilitate operations for its intended use and cleaning and maintenance.
21 CFR 211.42(c)(10)(iii). Air Supply Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
21 CFR 211.46(b). Equipment for Environmental Control Equipment for adequate control over air pressure, micro-organisms, dust, humidity and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
21 CFR 211.100(b). Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not recorded and justified.
21 CFR 211.160(b)(4). Establishment of calibration procedures Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed and deficiently written or followed.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.

Voluntary Action Indicated (VAI)

Dec 14, 2018

Drugs · Drug Quality Assurance

None posted

No Action Indicated (NAI)

Feb 17, 2017

Drugs · Drug Quality Assurance

None posted

Voluntary Action Indicated (VAI)

Jun 17, 2016

Drugs · Drug Quality Assurance

None posted

Voluntary Action Indicated (VAI)

Apr 7, 2015

Drugs · Drug Quality Assurance

None posted

Voluntary Action Indicated (VAI)

Jun 21, 2013

Drugs · Drug Quality Assurance

None posted

Voluntary Action Indicated (VAI)

May 19, 2012

Drugs · Drug Quality Assurance

None posted

Voluntary Action Indicated (VAI)

Oct 10, 2011

Drugs · Drug Quality Assurance

None posted

Voluntary Action Indicated (VAI)

Nov 13, 2009

Drugs · Drug Quality Assurance

None posted

Voluntary Action Indicated (VAI)

BROMHEXINE HCL (EXPECTORANT)Drugs · 64HDC01

Drug made outside good manufacturing practice

Oct 9, 2026

MINOXIDIL (ANTI-HYPERTENSIVE)Drugs · 62CDY41

Drug made outside good manufacturing practice

Oct 8, 2026

CARBAMAZEPINE (ANALGESIC)Drugs · 60LCA14

Drug made outside good manufacturing practice

Sep 23, 2026

FINASTERIDE (INHIBITOR (DECARBOXYLASE))Drugs · 64UDL06

Drug made outside good manufacturing practice

Sep 18, 2026

TAMOXIFEN CITRATE (ANTI-ESTROGEN)Drugs · 61UCA05

Unapproved new drug

Aug 23, 2026

MINOXIDIL (ANTI-HYPERTENSIVE)Drugs · 62CCL41

Unapproved new drug

Aug 14, 2026

INHIBITOR N.E.C.Drugs · 64UDA99

Drug made outside good manufacturing practice

Aug 6, 20262 lines

NALTREXONE (ANTAGONIST)Drugs · 60TCA15

Drug made outside good manufacturing practice

Aug 4, 2026

CHLORZOXAZONE (RELAXANT)Drugs · 65QBA31

Drug or device not listed with FDAUnapproved new drug

Aug 3, 2026

TAMOXIFEN CITRATE (ANTI-ESTROGEN)Drugs · 61UDY05

Drug made outside good manufacturing practice

Jul 21, 2026

SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)Drugs · 61NDY78

Drug made outside good manufacturing practice

Jul 21, 2026

ESCITALOPRAM OXALATEDrugs · 61NCA83

Unapproved new drug

May 29, 2026

PACLITAXEL (ANTI-NEOPLASTIC)Drugs · 62IIP91

Drug made outside good manufacturing practice

Apr 17, 2026

TACROLIMUS (IMMUNOSUPPRESSIVE)Drugs · 64TDY08

Drug made outside good manufacturing practice

Apr 17, 2026

ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)Drugs · 61JDA08

Drug made outside good manufacturing practiceDrug or device not listed with FDAUnapproved new drug

Apr 17, 2026

FLUOXETINE (ANTI-DEPRESSANT)Drugs · 61NCA29

Drug made outside good manufacturing practice

Mar 13, 2026

RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)Drugs · 66NDY04

Drug made outside good manufacturing practice

Feb 27, 2026

BUSPIRONE HCL (TRANQUILIZER)Drugs · 66MCA09

Drug made outside good manufacturing practice

Feb 26, 2026

VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.Foods · 54YGA99

Drug made outside good manufacturing practice

Jan 18, 2026

MINOXIDIL (ANTI-HYPERTENSIVE)Drugs · 62CCY41

Drug made outside good manufacturing practice

Jan 6, 2026

CLOPIDOGREL BISULFATE (ANTI-COAGULANT)Drugs · 61LDC38

Drug made outside good manufacturing practice

Dec 29, 2025

LEVOCARNITINE (NUTRIENT/TONIC)Drugs · 65CDY07

Drug made outside good manufacturing practice

Dec 12, 2025

EMOLLIENT, LUBRICANT, N.E.C.Drugs · 64DBK99

Drug made outside good manufacturing practice

Nov 10, 2025

PANTOPRAZOLE SODIUMDrugs · 62TAA07

Drug made outside good manufacturing practiceUnapproved new drug

Oct 14, 2025

MISCELLANEOUS PATENT MEDICINES, ETC.Drugs · 66VIY99

Drug made outside good manufacturing practiceUnapproved new drug

Oct 7, 2025

MISCELLANEOUS PATENT MEDICINES, ETC.Drugs · 66VDY99

Unapproved new drug

Sep 18, 2025

ANTI-COAGULANT, N.E.C.Drugs · 61LDB99

Drug made outside good manufacturing practiceDrug or device not listed with FDAUnapproved new drug

Aug 26, 2025

SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)Drugs · 61NCY78

Unapproved new drug

Jun 16, 2025

LACTULOSE (CATHARTIC)Drugs · 63HCK10

Drug made outside good manufacturing practice

Apr 11, 2025

LITHIUM CITRATE (ANTI-DEPRESSANT)Drugs · 61NCB71

Drug made outside good manufacturing practice

Mar 26, 2025

ANTI-ECZEMATIC N.E.C.Drugs · 61SAY99

Drug made outside good manufacturing practice

Mar 20, 2025

NAPHAZOLINE HCL (ADRENERGIC)Drugs · 60CDY46

Drug made outside good manufacturing practiceUnapproved new drug

Mar 4, 2025

VALPROIC ACID (ANTI-CONVULSANT)Drugs · 61MDA41

Drug made outside good manufacturing practice

Jan 31, 2025

LACTULOSE (CATHARTIC)Drugs · 63HCL10

Unapproved new drug

Dec 17, 2024

ACETAMINOPHEN (ANALGESIC)Drugs · 60LDC01

Unapproved new drug

Dec 5, 2024

IRBESARTAN (ANTI-HYPERTENSIVE - PART II)Drugs · 62OCB37

Drug made outside good manufacturing practice

Nov 22, 2024

PANTOPRAZOLE SODIUMDrugs · 62TDB07

Unapproved new drug

Nov 14, 2024

CHLORZOXAZONE (RELAXANT)Drugs · 65QDA31

Drug made outside good manufacturing practiceDrug or device not listed with FDAUnapproved new drug

Jul 12, 2024

DICLOFENAC SODIUM (ANTI-INFLAMMATORY)Drugs · 62GDY18

Drug made outside good manufacturing practice

Jul 2, 2024

DESVENLAFAXINE SUCCINATEDrugs · 61NDC84

Drug made outside good manufacturing practice

Jun 17, 2024

OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART IIDrugs · 66NDY02

Drug made outside good manufacturing practice

Apr 9, 2024

LACTULOSE (CATHARTIC)Drugs · 63HDA10

Drug made outside good manufacturing practice

Apr 1, 2024

FINASTERIDE (INHIBITOR (DECARBOXYLASE))Drugs · 64UDA06

Drug made outside good manufacturing practice

Mar 21, 2024

METOPROLOL SUCCINATE (ANTI-HYPERTENSIVE - PART II)Drugs · 62OCY43

Drug made outside good manufacturing practice

Mar 1, 2024

HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)Drugs · 62LCA29

Drug made outside good manufacturing practice

Jan 25, 20248 lines

TACROLIMUS (IMMUNOSUPPRESSIVE)Drugs · 64TCO08

Drug made outside good manufacturing practice

Jan 19, 20245 lines

SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)Drugs · 61NCA78

Drug made outside good manufacturing practice

Jan 19, 20242 lines

ANTINEOPLASTIC, NECOther · 58DCZ99

Drug made outside good manufacturing practice

Jan 10, 20242 lines

OXYBUTYNIN CHLORIDE (ANTI-CHOLINERGIC)Drugs · 61KCB34

Drug made outside good manufacturing practice

Jan 10, 2024