Dabur India Limited

FDA establishment 3001413302, Dadra And Nagar Haveli, India. Part of Dabur India Limited'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: 3
Official action indicated: 1
Last inspection ended: Jan 16, 2026
Warning letters: 1
Import refusals since 2024: 99

Inspections by Fiscal Year

FY2018 to FY2027 to date; 1 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.

02019

02021

02023

02025

02027

Most Cited at This Site

Inspections citing each reference

Inspections

3 inspections, newest first

Ended	Product and area	Citations	Classification
Jan 16, 2026	Drugs · Drug Quality Assurance	7 cited references 21 CFR 211.56(a). Sanitation--buildings not clean, free of infestation Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and free of infestation by rodents, birds insects, and other vermin. 21 CFR 211.180(e)(1). Review of representative number of batches Written procedures are not established and followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected. 21 CFR 211.65(a). Equipment construction - reactive surfaces Equipment surfaces that contact components and in-process materials are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. 21 CFR 211.22(a). Authority lacking to review records, investigate errors The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred. 21 CFR 211.67(b)(5). Cleaning SOPs/equipment protection Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment from contamination prior to use. 21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. 21 CFR 211.192. Quality control unit review of records Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.	Official Action Indicated (OAI)
Dec 6, 2019	Drugs · Drug Quality Assurance	2 cited references 21 CFR 211.68(b). Computer control of master formula records Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Electronic records are used, but they do not meet system access limitation and audit trail requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records. 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.	Voluntary Action Indicated (VAI)
Oct 14, 2016	Drugs · Drug Quality Assurance	None posted	Voluntary Action Indicated (VAI)

Warning Letters

Letters naming this establishment; each opens the letter

Data integrity, Cleaning validation, Process validationJul 24, 2026

Import Refusals

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

Product	Charges	Latest
SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RAG04	Drug made outside good manufacturing practice	Sep 24, 20263 lines
MENTHOL (ANTI-PRURITIC)Drugs · 62MBY08	Drug made outside good manufacturing practice	Sep 24, 2026
SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RBG04	Drug made outside good manufacturing practiceDrug or device not listed with FDA	Sep 24, 2026
MISCELLANEOUS ANTIBIOTICS, N.E.C.Drugs · 56KBO99	Drug made outside good manufacturing practiceMaker not registered with FDADrug or device not listed with FDA	Aug 20, 2026
PROTECTANT N.E.C.Drugs · 65LAJ99	Drug made outside good manufacturing practiceMaker not registered with FDA	Aug 20, 2026
PROTECTANT N.E.C.Drugs · 65LBY99	Drug made outside good manufacturing practice	Aug 14, 20265 lines
STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RBJ06	Drug made outside good manufacturing practice	Aug 14, 20264 lines
SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RBJ04	Drug made outside good manufacturing practice	Aug 14, 2026
STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RBJ06	Drug made outside good manufacturing practiceMaker not registered with FDADrug or device not listed with FDA	Jul 31, 2026
STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RBY06	Drug made outside good manufacturing practice	Jul 21, 202614 lines
SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RAG05	Drug made outside good manufacturing practice	Jul 21, 202614 lines
PROTECTANT N.E.C.Drugs · 65LBJ99	Drug made outside good manufacturing practice	Jul 20, 20262 lines
SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RAY05	Drug made outside good manufacturing practice	Jul 20, 2026
SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RBY04	Drug made outside good manufacturing practice	Jul 16, 20267 lines
SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RBY05	Drug made outside good manufacturing practice	Jul 15, 202614 lines
STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RBY06	Drug made outside good manufacturing practiceDrug or device not listed with FDAUnapproved new drug	Jul 13, 202616 lines
PROTECTANT N.E.C.Drugs · 65LBO99	Drug made outside good manufacturing practice	Jul 9, 20262 lines
SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RAG04	Drug made outside good manufacturing practiceDrug or device not listed with FDA	Jul 1, 2026
HERBALS & BOTANICALS (NOT TEAS), N.E.C.Foods · 54FCA99	Ingredients not listedSTD IDENT	Jun 23, 2026
CAMPHOR (ANTI-PRURITIC)Drugs · 62MBJ01	Drug or device not listed with FDA	Nov 20, 2025
DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)Cosmetics · 53IG01	Unapproved new drug	May 23, 20256 lines
MISCELLANEOUS PATENT MEDICINES, ETC.Drugs · 66VAY99	Unapproved new drug	May 23, 2025
MISCELLANEOUS PATENT MEDICINES, ETC.Drugs · 66VBY99	Maker not registered with FDADrug or device not listed with FDAUnapproved new drug	Jun 4, 2024

Identifiers

FEI number: 3001413302
FDA firm profile: Data Dashboard
Company: Dabur India Limited

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. 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 and warning letters

Ended

Product and area

Citations

Classification

Jan 16, 2026

Drugs · Drug Quality Assurance

7 cited references

21 CFR 211.56(a). Sanitation--buildings not clean, free of infestation Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and free of infestation by rodents, birds insects, and other vermin.
21 CFR 211.180(e)(1). Review of representative number of batches Written procedures are not established and followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
21 CFR 211.65(a). Equipment construction - reactive surfaces Equipment surfaces that contact components and in-process materials are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
21 CFR 211.22(a). Authority lacking to review records, investigate errors The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
21 CFR 211.67(b)(5). Cleaning SOPs/equipment protection Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment from contamination prior to use.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
21 CFR 211.192. Quality control unit review of records Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.

Official Action Indicated (OAI)

Dec 6, 2019

Drugs · Drug Quality Assurance

2 cited references

21 CFR 211.68(b). Computer control of master formula records Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Electronic records are used, but they do not meet system access limitation and audit trail requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
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.

Voluntary Action Indicated (VAI)

Oct 14, 2016

Drugs · Drug Quality Assurance

None posted

Voluntary Action Indicated (VAI)

Product

Charges

Latest

SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RAG04

Drug made outside good manufacturing practice

Sep 24, 20263 lines

MENTHOL (ANTI-PRURITIC)Drugs · 62MBY08

Drug made outside good manufacturing practice

Sep 24, 2026

SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RBG04

Drug made outside good manufacturing practiceDrug or device not listed with FDA

Sep 24, 2026

MISCELLANEOUS ANTIBIOTICS, N.E.C.Drugs · 56KBO99

Drug made outside good manufacturing practiceMaker not registered with FDADrug or device not listed with FDA

Aug 20, 2026

PROTECTANT N.E.C.Drugs · 65LAJ99

Drug made outside good manufacturing practiceMaker not registered with FDA

Aug 20, 2026

PROTECTANT N.E.C.Drugs · 65LBY99

Drug made outside good manufacturing practice

Aug 14, 20265 lines

STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RBJ06

Drug made outside good manufacturing practice

Aug 14, 20264 lines

SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RBJ04

Drug made outside good manufacturing practice

Aug 14, 2026

STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RBJ06

Drug made outside good manufacturing practiceMaker not registered with FDADrug or device not listed with FDA

Jul 31, 2026

STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RBY06

Drug made outside good manufacturing practice

Jul 21, 202614 lines

SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RAG05

Drug made outside good manufacturing practice

Jul 21, 202614 lines

PROTECTANT N.E.C.Drugs · 65LBJ99

Drug made outside good manufacturing practice

Jul 20, 20262 lines

SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RAY05

Drug made outside good manufacturing practice

Jul 20, 2026

SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RBY04

Drug made outside good manufacturing practice

Jul 16, 20267 lines

SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RBY05

Drug made outside good manufacturing practice

Jul 15, 202614 lines

STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RBY06

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

Jul 13, 202616 lines

PROTECTANT N.E.C.Drugs · 65LBO99

Drug made outside good manufacturing practice

Jul 9, 20262 lines

SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RAG04

Drug made outside good manufacturing practiceDrug or device not listed with FDA

Jul 1, 2026

HERBALS & BOTANICALS (NOT TEAS), N.E.C.Foods · 54FCA99

Ingredients not listedSTD IDENT

Jun 23, 2026

CAMPHOR (ANTI-PRURITIC)Drugs · 62MBJ01

Drug or device not listed with FDA

Nov 20, 2025

DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)Cosmetics · 53IG01

Unapproved new drug

May 23, 20256 lines

MISCELLANEOUS PATENT MEDICINES, ETC.Drugs · 66VAY99

Unapproved new drug

May 23, 2025

MISCELLANEOUS PATENT MEDICINES, ETC.Drugs · 66VBY99

Maker not registered with FDADrug or device not listed with FDAUnapproved new drug

Jun 4, 2024