Qualgen LLC — FDA 483 Findings

Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

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

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

Procedures describing in sufficient detail the controls employed for the issuance of labeling are not written and followed.

Your fir m failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

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

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

Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.

Master production and control records lack a description of the drug product containers, closures and packaging materials.

Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.

The batch production and control records are deficient in that they do not include complete labeling control records, specimen and copy of labeling.

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