Firm Record

Shilpa Medicare Limited findings history

35 findings from 5 inspection documents published by regulators. Each row below says what its date means.

US FDAHealth Canada 2017-12-08 ~ 2026-01-15 5 documents 35 findings

Areas cited

Equipment and facilityAseptic processing and sterility assuranceOther quality systemLaboratory and QC controlsContamination controlDeviation, CAPA, and investigationRegulatory reporting and change controlCleaning validationMaterial and supplier controlComputer system validationQuality unit oversight

Published inspection documents

2026-01-15 US FDA 8 findingsAseptic processing and sterility assurance · Contamination control · Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions. 2022-09-12 Health Canada 10 findingsRegulatory reporting and change control · Aseptic processing and sterility assurance · Other quality system · Cleaning validation · Contamination control · Material and supplier control · Equipment and facility The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved. 2020-04-02 US FDA 5 findingsOther quality system · Aseptic processing and sterility assurance · Laboratory and QC controls · Equipment and facility Drug prndud ~amples are uor representative of the entire batch and properly identified A. 2019-08-22 US FDA 3 findingsEquipment and facility · Computer system validation Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the APT finished materials. 2017-12-08 US FDA 9 findingsOther quality system · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility · Quality unit oversight · Laboratory and QC controls Scientific rational could not be provided for the following commercial product specifications: A.

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.

Full history of Shilpa Medicare Limited — including inspection classifications Browse by document Go to Findings search