As the pharmaceutical supply chain has grown more geographically diverse, drugmakers have leaned more and more on contract manufacturers to help carry the load. But bringing on a production partner can pose quality risks—a reality Georgia-based Acella Pharmaceuticals is finding out the hard way.
The FDA cited Acella after quality control issues with a contract manufacturer led the drugmaker to pull lots of its prescription NP Thyroid med off shelves back in May, according to a warning letter posted online Tuesday.
During an investigation between December and January, FDA investigators found Acella failed to use appropriate assays for the contract-manufactured active pharmaceutical ingredients (API) used in its thyroid drug: levothyroxine and liothyronine.
While Acella eventually corrected those errors, a May follow-up FDA investigation at its CMO’s facility found that 13 lots of NP Thyroid exceeded the specified strength. Acella agreed the same month to voluntarily recall those lots and acknowledged two side-effects reports.
The FDA noted that due to the “narrow therapeutic range” of NP Thyroid, out-of-spec dosing could pose serious side effects for patients who take the drug.
In addition, Acella failed to pursue a long-term stability study for lots of NP Thyroid produced by its CMO and a new API supplier back in May 2019, the FDA said. Almost a year after manufacturing, validation batches of the drug had still not been studied for long-term potency, casting doubts on its shelf life, the FDA said.
Levothyroxine and liothyronine have been on the FDA’s radar in the past as part of a ban on a Chinese API supplier.
In August 2018, Westminster Pharmaceuticals recalled all lots of its generic thyroid med using levothyroxine and liothyronine in five dose forms because it was made with API from China’s Sichuan Friendly Pharmaceutical.
The FDA banned all products made by Sichuan Friendly in March of that year after an inspection found big problems at the Chinese company’s manufacturing plant. Westminster said at the time it used the Chinese API to make its thyroid drug before the FDA had put the ban in place.