Precision Pharmacy Center, LLC — FDA 483 Findings

Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

There is no written testing program designed to asses.s the stability characteristics of drug products.

Reports of analysis from component suppliers are accepted in lieu of testing each component fur conformity with al l appropriate wrinen specifications, without performing at least one specific identity test on each component and establishin g the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

Each batch of drug product reqwred to be free of objectionable microorganisms is not tested through appropriate laborator y testing.

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, quaJity and purity.