1Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
Inspection Record
Fusion Solution Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
The deviation investigations to reconcile bulk product or printed packaging materials were inadequate.
3Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. A preventative maintenance system had not been established for the equipment used in significant processing and/or testing operations
5Laboratory and QC controls
The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate. The education, experience, and/or oversight of the individual in charge of the manufacturing department was inadequate.
6Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
7Other quality system
Water treatment plants and distribution systems were not designed, constructed, or maintained to ensure a reliable and adequate source of water.
8Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
9Other quality system
The company's monitoring of water testing was inadequate.
10Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
11Material and supplier control
The segregation, rotation of stock, and/or the transportation of raw materials, packaging materials, intermediates, bulk drugs, and/or finished products was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-01-21. 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.
