Fallon Wellness Pharmacy LLC — FDA 483 Findings

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

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

Adequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production.

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

The separate or defined areas necessary to prevent contamination or mix-ups are deficient.

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

There is a lack of written procedures assigning responsibility, providing cleaning schedules and describing in sufficient detail the methods, equipment and materials to be used for sanitation.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.

Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.

There is no written testing program designed to assess th estability characteristics of drug products.