The FDA issued a warning letter to Maryland-based Izeen Pharma for significant violations of current good manufacturing practices and misbranding of its thyroid tablets.
The warning followed up on a 2018 inspection of Izeen’s Frederick, Md. facility. The agency’s investigators observed multiple failures related to the firm’s production and distribution of thyroid tablets levothyroxine and liothyronine.
The agency flagged the firm’s failure to properly investigate discrepancies and batch failures. For instance, it did not find the root cause of out-of-specification results for its thyroid powder.
The agency also cited the firm for failing to properly implement a corrective action and prevention action plan following complaints of tablet size variation and tablet disintegration.