Firm Record
Cipla Limited findings history
56 findings from 9 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Aseptic processing and sterility assuranceQuality unit oversightEquipment and facilityDeviation, CAPA, and investigationOther quality systemComplaint and recall handlingLaboratory and QC controlsMaterial and supplier controlComputer system validationProcess validationStability and storage
Published inspection documents
2024-06-26
US FDA
6 findingsLaboratory and QC controls · Aseptic processing and sterility assurance · Computer system validation · Material and supplier control · Quality unit oversight The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
2024-04-10
US FDA
4 findingsDeviation, CAPA, and investigation · Equipment and facility · Quality unit oversight Failure to ensur~ all production deviations are reported and evaluated, and that critical deviations are investigated and the conclusions are recorded.
2023-11-21
US FDA
3 findingsAseptic processing and sterility assurance · Quality unit oversight · Complaint and recall handling Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). Media Fill Contamination Incidents You failed to appropriately evaluate a pattern of media fill failures in your facility and afford sufficient attention to potential correlations among these contamination events…
2023-03-02
US FDA
8 findingsAseptic processing and sterility assurance · Other quality system · Computer system validation · Quality unit oversight · Deviation, CAPA, and investigation · Complaint and recall handling Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
2022-09-21
US FDA
6 findingsComputer system validation · Aseptic processing and sterility assurance · Equipment and facility · Other quality system 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.
2019-10-11
US FDA
15 findingsOther quality system · Equipment and facility · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Quality unit oversight · Material and supplier control There are no written procedures for production and process conh'ols designed to assure that the diu g products have the identity, strength, quality, and purity they pmport or are represented to possess.
2018-04-20
US FDA
3 findingsProcess validation · Laboratory and QC controls · Stability and storage Written procedures for production and process controls are not designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
2018-03-27
US FDA
7 findingsMaterial and supplier control · Quality unit oversight · Laboratory and QC controls · Equipment and facility There is a failure to thoroughly review 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.
2016-11-29
US FDA
4 findingsComplaint and recall handling · Aseptic processing and sterility assurance · Equipment and facility · Deviation, CAPA, and investigation An Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
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.
