A drug repackager that specializes in single-dose repackaging has found itself in trouble with the FDA, which issued it a warning letter for both manufacturing issues and for marketing what the FDA said were unapproved and misbranded drugs.
The letter, posted by the FDA this week, was issued two weeks ago to GenPak Solutions. The letter sprung from an inspection of the Hilliard, OH, site in August 2015. Among the issues that inspectors laid out were problems with cleaning and sanitizing equipment that was used to package steroids, anticonvulsants, statins and antidepressants.
“You have no assurance that your cleaning processes are adequate to prevent unacceptable levels of residual product and cleaner on product contact surfaces for this equipment,” the agency told the company.
There were also issues noted with stability testing and quality control review. The letter notes that the company’s QC operation failed to review 42 of the 104 batch production records that inspectors looked over during the visit.
The warning also mentioned that the company appears to be marketing nearly 100 different drug products that would be classified as misbranded. It spotlighted the company’s AnodyneRx Patch Medicated Patch for “temporary relief of minor aches and muscle strains associated with arthritis, simple backache, strains, muscle soreness and stiffness.” The agency said the the drug is an unapproved new drug.
This is the second time in recent weeks that the FDA has cited a repackager. In April, the agency issued a warning letter to Decatur, AL-based Apothecares for taking liberties with the expiration dates on the APIs it repackages and having a quality unit that failed to approve records or written standard operating procedures (SOPs) for processes like expiration date extension, material quarantine, product distribution and equipment cleaning.
- read the warning letter
API repackager in hot water with FDA