1Equipment and facility
The premises were not designed, constructed, and/or maintained to prevent the entry of pests and/or foreign material into the building.
Inspection Record
Hetero Labs Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate. The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
3Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
4Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
5Material and supplier control
The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.
6Computer system validation
The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
7Other quality system
The recorded information or details were inadequate.
8Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
9Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
10Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-10-17. 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.
