Drug factory · FDA FEI 3006895982
Jubilant Generics Limited
Village Sikandarpur Bhainswal, Roorkee- Dehradun Highway, Bhagwanpur, Distt. Haridwar, Roorkee, India
Problems found, fixed voluntarily at FDA's last inspection, Feb 2, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2013: 1 with no problems, 4 with problems fixed voluntarily, 3 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 2, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 1, 2022 | Serious problems, FDA action | Drug Quality Assurance | 6 |
| Mar 12, 2021 | Serious problems, FDA action | Drug Quality Assurance | — |
| Nov 6, 2019 | Serious problems, FDA action | Drug Quality Assurance | 6 |
| Mar 23, 2017 | No problems found | Drug Quality Assurance | — |
| Apr 8, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 13, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 1, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Aug 1, 2022 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not followed and documented at the time of performance. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch. - Investigations of discrepancies, failures 21 CFR 211.192
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. - No written record of investigation 21 CFR 211.192
Written records are not always made of investigations into unexplained discrepancies. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Nov 6, 2019 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
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. - Scientifically sound laboratory controls 21 CFR 211.160(b)
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. - Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed. - Investigations of discrepancies, failures 21 CFR 211.192
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. - Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not suitably located to facilitate operations for its intended use.
Registered with FDA for: analysis; label; manufacture; pack.