1Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
Inspection Record
Shandong Xinhua Pharmaceutical Co., Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures. The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
3Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
4Equipment and facility
The segregation, rotation of stock, and/or the transportation of raw materials, packaging materials, intermediates, bulk drugs, and/or finished products was inadequate. The premises were not designed, constructed, and/or maintained to prevent the entry of pests and/or foreign material into the building.
5Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-03-11. 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.
