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FDA establishment 3008565058, Dhar, India. Part of Glenmark 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: 8
Official action indicated: 1
Last inspection ended: Feb 14, 2025
Warning letters: 1
Import refusals since 2024: 1
Import refusals 2014 to 2023: 4, first Jan 24, 2019
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.
21 CFR 211.22(c). Approve or reject procedures or specs The quality control unit lacks responsibility to approve all procedures or specifications impacting on the quality of drug products.
21 CFR 211.165(e). Test methods The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.42(c)(5). Mfg / Processing Operations Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Official Action Indicated (OAI)
Feb 25, 2020
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Sep 13, 2019
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
May 24, 2018
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Aug 26, 2017
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Feb 26, 2016
Drugs · Drug Quality Assurance
3 cited references
21 CFR 211.142. Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not established. Electronic records are used, but they do not meet systems validation, operational system check, employee accountability/responsibility policy, and systems documentation control requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
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 systems validation, system access limitation, audit trail, operational system check, employee accountability/responsibility policy, systems documentation control, and open systems control requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
21 CFR 211.110(a). Control procedures fail to include the following Control procedures fail to include tablet or capsule weight variation and adequacy of mixing to assure uniformity and homogeneity.
Voluntary Action Indicated (VAI)
Jul 24, 2015
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Oct 25, 2013
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Warning Letters
Letters naming this establishment; each opens the letter
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
Dhar, India. Part of