Custom Meds Inc. — FDA 483 Findings

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength ofe11ch active ingredient prior to release.

Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory 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, quality and purity.