Firm Record
Indoco Remedies Limited findings history
33 findings from 6 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Deviation, CAPA, and investigationQuality unit oversightAseptic processing and sterility assuranceComplaint and recall handlingEquipment and facilityDocumentation and recordsLaboratory and QC controlsStability and storageMaterial and supplier controlLabeling and packaging
Published inspection documents
2025-03-06
US FDA
5 findingsMaterial and supplier control · Quality unit oversight · Aseptic processing and sterility assurance · Complaint and recall handling Dete1minations of confo1mance to appropriate written specifications for acceptance are deficient for in- process materials. View the regulator's official source
2025-01-07
US FDA
7 findingsComplaint and recall handling · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Quality unit oversight Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Your investigations into product quality defect complaints are not consistently and scientifically supported and rely on flawed analyses to reach conclusions on product quality impact. For example: A. Your investigation into complaints of dispensing tip (nozzle) blockage associated with (b)(4) solution USP (b)(4) % ( (b)(4) ) and (b)(4) and (b)(4) solution USP, (b)(4) mg/ml and (b)(4) mg/mL ( (b)(4) ) concluded the tip blockage phenomena was due to improper storage by patients. You stated the ensuing exposure of product solutions to air resulted in the (b)(4) excipient in the formulations forming a film or precipitating and blocking the dispensing tips. Your investigation is deficient for reasons including, but not limited to… View the regulator's official source
2019-07-09
US FDA
3 findingsMaterial and supplier control · Deviation, CAPA, and investigation · Stability and storage Written procedures are not established that describe the examinations to be conducted on appropriate samples of in-process materials ofeach batch. View the regulator's official source
2019-02-12
US FDA
5 findingsDeviation, CAPA, and investigation · Documentation and records · Equipment and facility · 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 already distributed. View the regulator's official source
2018-02-15
US FDA
7 findingsStability and storage · Laboratory and QC controls · Quality unit oversight · Documentation and records · Labeling and packaging · Equipment and facility The written stability program for drug products does not include test intervals based on statistical criteria for each attribute examined to assure valid estimates of stability. View the regulator's official source
2016-11-29
US FDA
6 findingsComplaint and recall handling · Quality unit oversight · Equipment and facility · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation An -Field Alert Report was not submitted within three working days of receipt of information concerning bacteriological contamination and significant chemical, physical, or other change or deterioration in a distributed drug product. View the regulator's official source
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 2026-10-20, 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.
