ApotheCure Inc. — FDA 483 Findings

Batch production and control records do not include the weights and measures ofcomponents used in the course of processing each batch of drug product produced.

Each batch ofdrug product required to be free ofoqectionable micioorganisms is not tested through appropriate laboratory testing.

Reports ofanalysis from component suppliers are accepted in lieu oftesting each component for conformity with all appropriate written specifications, ~ithout perfonning at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation oftbe supplier's test results at appropriate intervals.

""'"'l'JWI~-~ 08/06/2007 - 08/13/2007 FEI~ 3000203232 ................__ 4001 McEwen Rd Ste 100 .,.,..,NIUIHMeiCT-~ Drug Manufacturer batch production and control records do not include a description of drug product containers and closures used ffor each bat ch of drug product produced.

Testing and release ofdrug product for ctistribution do not iJcJude appropriate laboratory determination ofsatisfactory : conformance to the final specifications and identity and strength ofeach active ingredient prior to release.

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

Each lot of a component that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.

Written procedures are not followed for the receipt and storage ofcomponents.

master production a nd control records lack complete manufacturing and control instructions, sampling and test ing procedures, and special notations.

Procedures designed to pi-event microbiological contamination ofdrug products purporting to be sterile do not include validation oftbe sterilization process.