1Other quality system
The electronic system was not validated for its intended use.
Inspection Record
Derma Sciences Canada, Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The recorded information or details were inadequate.
3Training and personnel
The written hygiene program was not being followed by plant personnel and/or visitors.
4Laboratory and QC controls
The quality control department did not undertake all of the required activities.
5Cleaning validation
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate. The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material. The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures. Dust was inadequately contained during fabrication, packaging, and/or labelling.
6Stability and storage
The temperature and/or humidity control was inadequate.
7Other quality system
The control of quarantine areas was inadequate.
8Material and supplier control
The premises were not laid out and/or designed for an optimal flow of personnel and/or materials to prevent cross-contamination and/or mix-ups between products.
9Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
10Equipment and facility
The usage logs for the equipment used for significant processing and/or testing operations were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-04-01. 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.
