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OTC Drug Manufacturer Warned On GMP Problems FDA Initially Found In 2010

Executive Summary

"In response to each of those inspections and compliance actions taken against your firm, you proposed specific remediations to fully address the violations," says FDA in warning letter to TG United. Firm in 2013 recalled 44 products – totaling some 688,000 containers plus 2.53m pills or tablets distributed in bulk – due to GMP deviations.

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