Pharma Packager Gets FDA Warning

GenPak Solutions cited for CGMP violations at Ohio facility.

Jul 27th, 2016
GenPak / Photo: genpak.net
GenPak / Photo: genpak.net

According to a PharmTech.com article, the FDA issued a warning letter to Ohio-based GenPak Solutions, citing “several current good manufacturing practice (CGMP) violations, unapproved new drug violations, and misbranding violations.” The FDA inspection took place in August of 2015, but the warning wasn’t administered until June 12th

After the inspection, the FDA determined that GenPak was repackaging, relabeling, and distributing new unapproved drugs. According to the article, the FDA found nearly 100 different misbranded products during the inspection.

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