CIPLA

Lack of Assurance of Sterility: environmental monitoring failure.

Lack of Assurance of Sterility

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.

Lack of Assurance of Sterility: Complaints received of defective container closure.

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.

CGMP Deviations

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline

cGMP deviations: Vials may not be sealed correctly affecting sterility.