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Paddock Laboratories

Executive Summary

Generic manufacturer is cited by FDA for good manufacturing practices violations at New Hope, Minn., plant in March 6 warning letter. Violations include quality control failures and defective equipment. "Your firm has a long history of cGMP violations," FDA wrote, "and we are very concerned about the apparent lack of cGMP oversight at your facility." Paddock said that it met with the agency on March 15 and is taking corrective actions
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PS037596

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