RC Outsourcing LLC — FDA 483 Findings

Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

Batch production and control records do not include complete information relating to the production and control of each batch .

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

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

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

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.