1Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
Inspection Record
CTX Life Sciences 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.
3Labeling and packaging
The written agreement for outsourcing fabrication, packaging or labelling, and/or testing activities was inadequate.
4Training and personnel
The training of personnel before new or revised standard operating procedures were implemented was inadequate.
5Computer system validation
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
6Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
7Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
8Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate. The availability, implementation, and/or quality of the written sanitation program was inadequate.
9Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
10Other quality system
The master formulas to control the manufacturing process were inadequate.
11Material and supplier control
The specifications for raw materials used to produce drugs did not meet pharmacopoeial standards.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-02-03. 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.
