RC Outsourcing LLC — FDA 483 Findings

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

Drug product expiration dates are not related to the storage conditions stated on the labeling, as determined by stability studies.

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.

Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

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

Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices and written procedures required by current good manufacturing practice regulations.

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