Packaging Facility Gets FDA Warning Letter

FDA issued a warning letter to GenPak Solutions’ Hilliard, Ohio facility following inspections performed in August 2015. The company was given FDA 483 forms for several current good manufacturing practice (CGMP) violations, unapproved new drug violations, and misbranding violations.

CGMP violations cited in the warning letter include cleaning and sanitization failures, failure to follow an adequate written testing program, failure to review production records, and failure to establish written procedures for production and process controls. FDA points out in the letter that the CGMP violations observed in the 2015 inspection are similar to violations found during a May 2013 inspection of the facility, but the company continued to release batches of repackaged drug products for distribution. “Your August 27, 2015, response promises the same corrective actions as your response to our May 2013 inspection.  You failed to implement adequate controls to ensure that the drug products you repackage and sell, such as steroids and statins, are integral, free of contamination, and stable throughout their shelf life,” FDA stated in the letter.

After the 2015 inspection, the agency determined that the company was repackaging, relabeling, and distributing unapproved new drugs. Other products were determined to be misbranded because of their toxicity, which made them potentially harmful, and therefore, they should be taken under the supervision of a licensed practitioner. Nearly 98 different products were found by FDA to be misbranded during the inspection.