PolyPeptide Laboratories Pvt Ltd — Health Canada Inspection Findings

The quarantine, sampling, testing, release of raw material, and/or the packaging materials prior to use were inadequate. The sampling, testing, and/or specifications for total microbial count were inadequate.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations.

The temperature and/or humidity control was inadequate. The premises were not constructed and/or maintained to allow cleaning and/or prevent the accumulation of foreign material. The premises and/or the manufacturing process were inadequate for minimizing contamination of the drugs and/or materials during fabrication and/or packaging.

The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions. The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.