Pharmagen Laboratories, Inc — 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.

Protective apparel is not worn as necessary to protect drug products from contamination .

Employees are not given training in the particular operations they perform as part oftheir fw1ction and current good manufacturing pr;actices.

The control systems necessary to prevent contamination or mix-ups are defic ient.

The accuracy, sensitivity, specificity, and reproducibility oftest rnetho<ls have not been established and documented.

Buildings used in the manufacture, processing, packing or holding ofdrug products are not maintained in a clean and sanitary condition .

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

There is no quality control unit.

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

A written record of each complaint is not maintained in a file designated for drug product complaints at the facility where the drug product was manufactured, processed or packed.

There is no written testing program designed to assess the stability characteristics ofdrug products.

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactor y performance to the final specification and identify and strenth of each active ingredient prior to release.

The master production and control records for each batch size of drug product are not prepared, dated, and signed by one person with a full handwritten s ignature and independently checked, dated, and signed by a second person.