Physician Preferred Medical, LLC — FDA 483 Findings

Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination ofthe drug product.

Drug product containers and closures were not sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.

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

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

Each batch ofdrug product required to be free ofobjectionable microorganisms is not tested through appropriate laboratory testing.

Written procedures are not established for the cleaning and maintenance ofequipment, including utensils, used in the manufacture, processing, packing or holding ofa drug product.

There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Master production and control records lack a statement oftheoretical yield including tbe maximum and minimum percentages of theoretical yield beyond which investigation is required.

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

Testing and release ofdrug product for distribution do not include appropriate laboratory determination ofsatisfactory conformance to the final specifications and identity and strength ofeach active ingredient prior to release.

The master production and control records are deficient in that they do not include complete manufacturing and procedures.

Laboratory controls do not include the establishment ofscientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards ofidentity, strength, quality and purity.

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

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

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation ofthe ste rilization process.

Equipment used in the manufacture, processing, packing or holding ofdrug products is not ofappropriate design to facilitate operations for its cleaning and maintenance.

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