Firm Record
Natco Pharma Limited findings history
65 findings from 10 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Deviation, CAPA, and investigationStability and storageContamination controlLaboratory and QC controlsOther quality systemAseptic processing and sterility assuranceEquipment and facilityComputer system validationQuality unit oversightProcess validationRegulatory reporting and change controlComplaint and recall handling
Published inspection documents
2025-07-10
US FDA
6 findingsAseptic processing and sterility assurance · Equipment and facility · Deviation, CAPA, and investigation Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
2025-01-15
Health Canada
11 findingsOther quality system · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Contamination control · Computer system validation The receipt, preparation, and/or handling of reagents and culture media was inadequate.
2025-01-15
Health Canada
5 findingsStability and storage · Contamination control · Deviation, CAPA, and investigation · Laboratory and QC controls The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
2025-01-15
Health Canada
6 findingsContamination control · Stability and storage · Deviation, CAPA, and investigation · Laboratory and QC controls · Other quality system The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
2025-01-15
Health Canada
8 findingsStability and storage · Contamination control · Laboratory and QC controls · Equipment and facility · Deviation, CAPA, and investigation The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
2025-01-15
Health Canada
4 findingsContamination control · Stability and storage · Laboratory and QC controls · Deviation, CAPA, and investigation The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
2023-11-01
US FDA
8 findingsDeviation, CAPA, and investigation · Quality unit oversight · Aseptic processing and sterility assurance · Process validation · Equipment and facility · Computer system validation 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.
2023-06-19
Health Canada
7 findingsDeviation, CAPA, and investigation · Contamination control · Regulatory reporting and change control · Stability and storage · Equipment and facility · Other quality system · Computer system validation The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
2023-06-19
Health Canada
5 findingsContamination control · Stability and storage · Deviation, CAPA, and investigation · Computer system validation · Other quality system The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
2017-02-01
US FDA
5 findingsQuality unit oversight · Aseptic processing and sterility assurance · Stability and storage · Complaint and recall handling · Laboratory and QC controls The responsibilities and procedures applicable to the quality control unit are not fully followed.
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.
