Liberty Drug & Surgical — FDA 483 Findings

Each lot ofa component, drug product container, and closure that is liable to microbiological contamination that is objectionable in view ofits intended use is not subjected to microbiological tests before use.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, Specifically, on 3/30/15, during the preparation of spraying IV bags of <Redac ted b4> with <Redacted b4> COITION OOSOI.ETE AMENDMENT1 Barba ra J.

Test procedures relative to appropriate laboratory testing for sterility and pyrogens are not followed.

Clothing of personnel engaged in the manufacturing, processing, packing, and holding of drug products is not a ppropriate for the duties they perform.

The flow of components, drug product containers,.

The written stability program for drug products does not include reliable, meaningful, and specific test methods .

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations.

Aseptic processing areas are deficient regarding systems for maintaining any equ ipment used to control the aseptic conditions.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.

Procedures describing the handling of written and oral complaints related to drug products are not written or followed.

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.