1Other quality system
The system for reviewing, revising, and approving standard operating procedures was inadequate.
Inspection Record
Srini Pharmaceuticals Pvt Ltd — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
3Equipment and facility
The preventative maintenance and repair of the equipment was inadequate.
4Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
5Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
6Equipment and facility
The design, construction, operation, and/or location of the equipment was inadequate for preventing contamination of the drug.
7Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
8Other quality system
The written specifications were inadequate.
9Equipment and facility
The design, construction, and/or location of the equipment did not allow adequate cleaning, sanitizing, and/or inspection of the equipment.
10Other quality system
The assessment to release finished products was inadequate.
11Complaint and recall handling
The written procedures for recalls were inadequate.
12Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
13Other quality system
The recorded information or details were inadequate.
14Material and supplier control
The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate. An audit report was not available or was inadequate under the raw material vendor certification program.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-09-01. The source is available at the link above.
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.
Translation and classification are automated and may differ in nuance from the source.
