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Lyne Labs cited for inadequate lab controls

This article was originally published in The Gold Sheet

Executive Summary

Lyne Laboratories of Brockton, Mass., was cited for inadequate lab controls in a Jan. 17 warning letter. The firm, a contract manufacturer of oral liquids, powders, semi-solids, tablets and liquid dose unit-dose packaging, was cited for failing to thoroughly review the failure of a batch or any of its components to meet specifications. FDA said the company has not completed an investigation into the chemical composition and potential patient risk for particulate matter found in its Calcitriol Injection. The firm was also cited for failure to establish adequate laboratory controls including scientifically sound and appropriate test procedures to assure that drug product components and drug products conform to appropriate standards of identity, strength, quality and purity

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