Pioneer Agro Industries — Health Canada Inspection Findings

The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.

The preventative maintenance and repair of the equipment was inadequate.

The receipt, preparation, and/or handling of reagents and culture media was inadequate.

The premises were not designed, constructed, operated, and/or maintained to allow clean and orderly conditions. The maintenance and/or monitoring of the ventilation system's air quality was inadequate.

Validation studies were not conducted in keeping with the predefined protocols. The recorded information or details were inadequate.

The monitoring procedures for microbial and/or environmental conditions were inadequate.

The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The handling of standard operating procedures for good manufacturing practices was inadequate.

The creation, maintenance, processing, and/or review of laboratory data was inadequate. The validation and/or the documentation of test methods was inadequate. The recorded information or details were inadequate.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

The ongoing stability program for a drug was inadequate.