D.R. Pharmacy, Inc. — FDA 483 Findings

There is no written testing program designed to assess the stability characteristics ofdrug products.

Each batch ofdrug product required to be free ofobjectionable m icroorganisms is not tested through appropriate laboratory testing_ Specifically, your firm does not evaluate any finished aqueous drug products administered orally for microbiological contamination.

Laboratory controls do not include the establishment ofscientifically sound and appropriate specifications designed to assure tbat drug products confonn to appropriate standards ofidentity, strength, quality and purity.

Testing and release ofdrug product for distribution do not include appropriate laboratory determination ofsatisfactory confonnance to the identity and strength ofeach active ingredient prior to release.

The batch production and control reoords are deficient in that they do not include documenta.tion ofthe acco mplishment of each s ignificant step in processing.

Approved components are not retested or reexamined as appropriate for identity, strength, quality and purity after stora.ge for long periods with subsequent approval or rejection by the quality control unit Specifically, A) Expired Active Phannaceuticallngredients were observed on 3/3fl0 15 near the production area.

Control procedures are not established which validate the performance ofthose manufacturing processes that may be responsible for causing variabi lity in the characteristics ofin-process material and the drug product Specifically, OIIITNCT~N«JPHiliE,.._ Producer of Non-Sterile Drugs I.