Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
FDA establishment 3006895982, Roorkee, India. Part of Jubilant Generics's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 8
Official action indicated: 3
Last inspection ended: Feb 2, 2024
Warning letters: 2
Inspections by Fiscal Year
FY2018 to FY2027 to date; 3 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 211.160(a). Following/documenting laboratory controls Established laboratory control mechanisms are not followed and documented at the time of performance.
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.
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 211.192. Written record of investigation incomplete Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
21 CFR 211.192. No written record of investigation Written records are not always made of investigations into unexplained discrepancies.
21 CFR 211.188. Prepared for each batch, include complete information Batch production and control records do not include complete information relating to the production and control of each batch.
Official Action Indicated (OAI)
Mar 12, 2021
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Nov 6, 2019
Drugs · Drug Quality Assurance
6 cited references
21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not suitably located to facilitate operations for its intended use.
21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
21 CFR 211.198(a). Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
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)
Mar 23, 2017
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Apr 8, 2016
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Mar 13, 2015
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Mar 1, 2013
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
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
Roorkee, India. Part of