The FDA hit Nebraska-based Ali Pharmaceutical Manufacturing with a warning letter that cited three critical issues at its Omaha production facility where it makes the porcine thyroid active pharmaceutical ingredient (API).
Porcine (pig) thyroid, is used to treat hypothyroidism, though it is not as preferred a treatment as levothyroxine. The porcine thyroid API can replace or supplement thyroid hormone for patients whose thyroid gland does not produce enough of the hormone.
In the letter, the FDA slammed Ali for "inadequate" remedial efforts following an inspection last September and October.
The agency cited the company with failing to show reproducibility, not following or establishing procedures for investigating manufacturing deviations and failing to ensure API lots meet certain specifications before blending them with other lots.
“The porcine thyroid … you manufactured is used to produce drug products to treat hypothyroidism,” the FDA said in the warning letter. “Because of the narrow therapeutic range of these products, proper blending and manufacture of your intermediate that is appropriately evaluated through process validation is essential to prevent patients from receiving insufficient or excessive doses.”
If Ali doesn't correct the issues, the company could be face "regulatory or legal action" or be barred from winning federal contracts, the FDA said.