Medical Center Pharmacy, Inc — FDA 483 Findings

Each batch ofdrug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conforma nce to such requirements.

Equipment for adequate control over air pressure is not prov ided when appropriate for the manufacture, processing, packing or holding ofa drug product.

There is no writte n testing program designed to assess the stabil ity characterist ics of drug products.

The operations relating to the manufacture, processing, and packing ofpenicillin are not performed in facilities separate from those used for other drug products for human use.

Procedures designed to prevent obj ectionable microorganisms in drug pro ducts not required to be sterile are not established.

Procedures designed to prevent m icrobiological contamination of drug products purporting to be steril e do no t include adequate validat ion of the ste ri I ization process.

Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.

Aseptic processing areas are de fic ient regarding the system for cleaning and d isinfecting the equipment to produce aseptic conditions.

Equipment used in the manufacture, processing, packing or holding ofdrug products is not of appropriate design to faci litate operations for its intended use and cleaning and maintenance.

The calibration of instruments and gauges is not done at suitable intervals .

Drug products fai ling to meet established standards, specifications, and quality control criteria are not rejected.

Clothing of personnel engaged in the manu facturing, processing, and packing of dr ug products is not appropriate for the duties they perform.

Testing and release of drug product for distri bution do not incl ude appropriate laboratory determination of satisfactory conformance to the final specifications and ident ity and strength ofeach active ingred ient prior to release.