1Training and personnel
The effectiveness of the training was not assessed by the firm. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
Inspection Record
Anjan Drug Private Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The premises were not designed, constructed, and/or maintained to prevent the entry of pests and/or foreign material into the building. The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
3Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
4Laboratory and QC controls
The test methods were not validated and/or the results were not documented.
5Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
6Complaint and recall handling
The written procedures for recalls were inadequate.
7Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
8Equipment and facility
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 usage logs for the equipment used for significant processing and/or testing operations were inadequate.
9Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
10Material and supplier control
The specifications for any packaging materials were incomplete or inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-04-07. 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.
