Qualgen LLC — FDA 483 Findings

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

The written stability testing program is not followed .

The master production and control records are deficient in that they do not include complete manufacturing and control and instructions and sampling and testing and procedures and specifications Specifically, a) Your firm does not document in the batch records for the testosterone and estradiol pellets, the date that the pellets were put into vials and by whom.

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

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

DA're(S) Of INSPECTIO~ 8/24/2015-9/17/2015* FEINUM8ER 3011286349 STREET AOCRESS 14844 Bristol Park Blvd TVPEESTAill.tSl-IMENI INSPC-cTEO Outsourcing Facility Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.

Distribution records do not contain the name and strength of the drug product and description of dosage form and name and address of consignee and date and quantity shipped and lot or control number of drug product .

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

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

Procedures designed to prevent microbio logical cont am ination of drug products purporting to be steri le do not inclu de validation of the steril izat ion process.

In-process specifications are not consistent with drug product final specifications and derived from previous acceptable process average and process variability estimates where possible and determined by the application of suitable statistical procedures where appropriate .

Employees engaged in the manufacture and processing and packing and holding of a drug product lack the education and training and experience requ ired to perform their assigned functions.