Drug factory · FDA FEI 3002807979
Sun Pharmaceutical Industries Limited
Plot No. A-41, Industrial Area Phase-VIII A, S.A.S. Nagar, Mohali, India
Serious problems, FDA action at FDA's last inspection, Aug 12, 2022.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
7 drug inspections on record since 2011: 2 with no problems, 3 with problems fixed voluntarily, 2 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Diltiazem | Makes it | Caraco Pharmaceutical Laboratories, Ltd. | 63304-718, 63304-719, 63304-720 +2 |
| Droxidopa | Makes it | Caraco Pharmaceutical Laboratories, Ltd. | 63304-086, 63304-104, 63304-112 |
| Duloxetine | Makes it | Caraco Pharmaceutical Laboratories, Ltd. | 47335-616, 47335-617, 47335-618 +1 |
| Mesalamine | Makes it | Caraco Pharmaceutical Laboratories, Ltd. | 63304-089 |
| Pantoprazole | Makes it and tests it | Caraco Pharmaceutical Laboratories, Ltd., Northstar Rx LLC. | 62756-071, 72603-317 |
| Ranolazine | Makes it | Caraco Pharmaceutical Laboratories, Ltd. | 47335-624, 47335-625 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 12, 2022 | Serious problems, FDA action | Drug Quality Assurance | 6 |
| Feb 7, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 10, 2019 | No problems found | Drug Quality Assurance | — |
| Sep 14, 2018 | No problems found | Drug Quality Assurance | — |
| Nov 16, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 12, 2012 | Serious problems, FDA action | Drug Quality Assurance | — |
| Jun 22, 2011 | 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 12, 2022 inspection
- Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and approved by the quality control unit. - Following/documenting laboratory controls 21 CFR 211.160(a)
Established sampling plans, test procedures and laboratory control mechanisms are not documented at the time of performance. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. - Written Procedures Not Followed 21 CFR 211.80(a)
Written procedures are not followed for the testing of components.
Registered with FDA for: analysis; manufacture.