Edge Pharma, 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 the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

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

Routine calibration, inspection and checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.

Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.

The labels of your outsourcing facility's drug products are deficient.

The written stability testing program is not followed.

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

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

Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

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

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