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Executive Summary

New quality assurance initiatives are underway at the company following the receipt of a July 21 warning letter from FDA. Improvements are being made in the areas of cleaning validation of certain compounding tanks and information system data storage. FDA advised the company that its initial response to the agency's June inspection report inadequately addressed the problems found during inspection. The company has until Aug. 11 to submit a second response more fully demonstrating written procedures
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PS034607

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