Intact Pharmaceuticals LLC. — FDA 483 Findings

Equipment surfaces that contact drug products are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

Routine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.

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

Clothing ofpersonnel engaged in the manufacturing and processing of drug products is not appropriate for the duties they perform.

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

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.

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

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

Individuals responsible for supervising the manufacture and processing of a drug product lack the training to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.

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.