Firm Record
Sun Pharmaceutical Industries Ltd. findings history
122 findings from 17 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Equipment and facilityDeviation, CAPA, and investigationOther quality systemAseptic processing and sterility assuranceLaboratory and QC controlsQuality unit oversightStability and storageContamination controlMaterial and supplier controlTraining and personnelComplaint and recall handlingProcess validationCleaning validationComputer system validationDocumentation and recordsRegulatory reporting and change controlEnvironmental monitoring
Published inspection documents
2026-03-30
EMA (Europe)
1 findingsComplaint and recall handling Critical finding #1: Impact assessments of major deviations, which have impact on the validated status of the process, are not performed sufficiently, and in a timely manner. Impact on batches in the market is insufficiently assessed. This was observed in 13 out of 57 assessed products marketed in the EU, namely: Atorvastatin tablets, Isotretinoin capsules, Olanzapine tablets, Candesartan tablets, Levetiracetam tablets, Esomeprazole capsules, Esomeprazole tablets, Gliclazide tablets, Pantoprazole tablets, Perindopril tablets, Ramipril tablets, Rosuvastatin tablets and Valsartan tablets. Critical finding #2: The extent to which SPL communicates significant product quality-related issues with the EU batch release site and EU authorities is not sufficient. The involvement of the EU QP in any ongoing investigations, rejections, OOS/OOT results and other notifications, which could affect the quality of EU products is insufficient. Involvement of the EU-QP in the product assessment reports could not be demonstrated. EU-QP involvement was only demonstrated during recalls.
Action taken/proposed by the NCA: Withdrawal, of current valid GMP certificate No. NL/H 24/2049272 IGJ has the intention not to grant a new GMP certificate and to issue a Non-Compliance Statement upon finalization of the inspection report. This proposed decision was communicated with the company upon receival of the draft inspection report from IGJ. Following this decision the current GMP certificate (NL/H 24/2049272) previously granted based on the previous inspection in October 2023 will be withdrawn from EudraGMDP. Because of the second critical finding, IGJ has decided to not follow the option of issuing a partial GMP certificate. A re-inspection will be performed on the basis of the company plan of action to address the deficiencies (currently not scheduled yet). After a positive result following the re-inspection a new GMP certificate will be issued and this Non-Compliance Statement withdrawn. Recall of batches already released At present, IGJ is awaiting an assessment which products are considered critical for the Dutch market. At the same time, IGJ is awaiting an impact assessment from the MAH for continued batch certification. Therefore, currently not all information is available to determine whether a recall is deemed necessary based on the critical findings. IGJ is only considering market actions for the 13 products that are in scope of the first critical finding (see restrictions in Part 2). Each Member State is asked to determine, based on the provided product list of this Sun-site, which medicinal products are considered critical for the national market. In case IGJ decides on market actions required, a rapid alert will be initiated separately.
2025-07-09
US FDA
8 findingsLaboratory and QC controls · Equipment and facility · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Process validation · Documentation and records Laborato1y controls do not include the establishment ofscientifically sound and appropriate test procedures designed to assure that diug products confo1m to appropriate standards of identity, strength, quality and purity.
2024-11-18
Health Canada
12 findingsAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Material and supplier control · Contamination control · Equipment and facility · Regulatory reporting and change control · Other quality system The company did not take precautions to minimize contamination during all processing prior to sterilization. The number of samples taken for environmental monitoring was insufficient.
2024-05-06
Health Canada
9 findingsMaterial and supplier control · Cleaning validation · Stability and storage · Contamination control · Other quality system · Computer system validation · Equipment and facility Printed packaging materials were not stored in an area with restricted access.
2024-04-17
US FDA
6 findingsDeviation, CAPA, and investigation · Equipment and facility · Complaint and recall handling · Quality unit oversight · Laboratory and QC controls There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its components to meet any of its specifications whether or not the batch has been ah eady distributed.
2024-03-11
Health Canada
4 findingsOther quality system · Deviation, CAPA, and investigation · Contamination control The written specifications were inadequate.
2024-02-05
Health Canada
15 findingsStability and storage · Equipment and facility · Other quality system · Deviation, CAPA, and investigation · Material and supplier control · Aseptic processing and sterility assurance The temperature and/or humidity control was inadequate.
2023-10-16
US FDA
7 findingsCleaning validation · Equipment and facility · Environmental monitoring · Aseptic processing and sterility assurance Inadequately cleaned and maintained equipment can lead to cross contamination and poor quality drug products. Your response states that the (b)(4) was not disassembled during the cleaning process because engineering staff was not available. The residue and powder were from the previously manufactured drug product (which was the same drug). You also confirm the shiny fragments on the (b)(4) gaskets are (b)(4) and stated that the shedding of metal fragments most likely…
2023-06-26
Health Canada
3 findingsMaterial and supplier control · Computer system validation · Equipment and facility The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products.
2022-06-13
Health Canada
9 findingsDeviation, CAPA, and investigation · Contamination control · Computer system validation · Cleaning validation · Laboratory and QC controls · Training and personnel · Equipment and facility The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
2022-05-13
US FDA
10 findingsAseptic processing and sterility assurance · Laboratory and QC controls · Stability and storage · Equipment and facility · Deviation, CAPA, and investigation · Quality unit oversight · Training and personnel Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
2019-12-20
US FDA
8 findingsAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Process validation · Laboratory and QC controls · Material and supplier control · Quality unit oversight Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
2019-06-21
US FDA
4 findingsOther quality system · Aseptic processing and sterility assurance · Laboratory and QC controls Design plans that describe or reference the design and development activities and define responsibility for implementation have not been adequately established.
2018-09-10
US FDA
5 findingsLaboratory and QC controls · Stability and storage · Contamination control · Quality unit oversight · Process validation 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.
2018-03-06
US FDA
3 findingsOther quality system · Aseptic processing and sterility assurance · Equipment and facility Written procedures are lacking which describe in sufficient detail the sampling, testing, approval and rejection of drug product containers and closures.
2017-04-21
US FDA
10 findingsOther quality system · Training and personnel · Equipment and facility · Documentation and records · Quality unit oversight · Complaint and recall handling · Deviation, CAPA, and investigation Warehouse procedure is not followed.
2016-12-13
US FDA
8 findingsStability and storage · Training and personnel · Quality unit oversight · Complaint and recall handling · Other quality system · Laboratory and QC controls Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
About this page
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
What is included. As of 2026-09-03, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.
Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.
