1Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
Inspection Record
Nephron Pharmaceuticals Corporation — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
The company's cleaning of the premises and the equipment in aseptic areas was inadequate. The company did not take precautions to minimize contamination during all processing prior to sterilization. Sterile disinfectants were not used in Grade A and B areas.
3Aseptic processing and sterility assurance
In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate. The validation of aseptic processing was inadequate.
4Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
5Material and supplier control
Printed packaging materials were not stored in an area with restricted access.
6Aseptic processing and sterility assurance
The portable particle counters were inadequate to classify the airborne particulates in aseptic or clean areas.
7Other quality system
The education, experience, and/or oversight of the individual in charge of the manufacturing department was inadequate.
8Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
9Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The procedures in place were inadequate for the storage, transportation, records, and/or testing of purchased media. The monitoring procedures for microbial and/or environmental conditions were inadequate.
10Material and supplier control
Each container of a lot of raw materials was not tested to identify its contents with a specific, discriminating test.
11Equipment and facility
The maintenance of records was inadequate.
12Other quality system
The written clothing standards for each environmental grade were inadequate.
13Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
14Training and personnel
The health examinations of personnel (pre-employment and/or ongoing) were inadequate.
15Material and supplier control
The standard operating procedures or records for shipping and receiving raw materials were inadequate.
16Equipment and facility
The validation of equipment or the planned maintenance of equipment was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-10-16. 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.
