Farmakeio Outsourcing LLC — 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 of each active ingredient prior to release.

Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.

Processing areas are deficient regarding the system for monitoring environmental conditions.

Written procedures are not drafted, reviewed and approved by the appropriate organizational units.

The container labels of your outsourcing facility's drug products are deficient.

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.

The labels of your outsourcing facility's drug products are deficient.