1Other quality system
The implementation of a self-inspection program was inadequate.
Inspection Record
Germiphene Corporation — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
The written procedures for recalls were inadequate.
3Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
4Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
5Equipment and facility
Materials, bulk containers, major items of equipment, and/or the rooms were not properly identified. The protection of products and/or materials from contamination was inadequate.
6Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
7Stability and storage
The design of the drug stability study was inadequate and/or not justified with a documented rationale.
8Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
9Material and supplier control
A reduced retesting program for raw materials was in place without the raw material vendor certification.
10Laboratory and QC controls
The quality control department's approval was inadequate for raw materials, packaging materials, labelling, finished products, and/or products being reprocessed.
11Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate. The recorded information or details were inadequate.
12Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
13Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
14Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
15Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-03-17. 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.
