Sri Krishna Pharmaceuticals Ltd — Health Canada Inspection Findings

The quality control department did not appropriately approve, assess, and/or document the reprocessing and/or reworking of a lot and/or batch. The quarantine, sampling, testing, release of raw material, and/or the packaging materials prior to use were inadequate.

The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures. The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.

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 creation, maintenance, processing, and/or review of laboratory data was inadequate.