Inspectors from the US Food and Drug Administration (FDA) visited Seindni’s facility in Seoul, South Korea in May, and issued a Form 483 with several observations, to which the firm never responded.
In August, the FDA banned products made at the site from entering the US through Import Alert 66-40, and last week the Agency sent Seindi a warning letter highlighting violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals at the plant.
“Your firm lacks an adequate quality unit,” the letter stated. “You utilize contract manufacturers to manufacture your over the counter (OTC) drug products distributed to the United States. You explained to our investigator that you make finished product release decisions over the phone with your contract manufacturer, based on whether test results meet pre-established specifications.”
Seidni mostly makes snail-based cosmetic products. However, some of its products - specifically its skin protectant range - are classified as over-the-counter (OTC) sunscreen medicines by the FDA.
The letter added Seidni failed to have procedures covering the batch release process, and its quality unit lacked documentation to demonstrate acceptability of batch manufacturing and product quality.
Furthermore, the Agency said Seidni admitted during the inspection that its contract manufacturing organisations (CMOs) do not make its OTC products in conformance with cGMP.
“You have released some drugs for which neither you nor your contract manufacturers conducted release tests for identity and strength of active ingredients. As a result, some of your drugs are distributed without confirmation that they meet specifications for identity and strength of their active ingredients.”
Under section 501(a)(2)(B) of the Food, Drug, and Cosmetic Act (FD&C) Act, drugmakers are responsible for the quality of drugs they produce, regardless whether a third-party manufacturer is involved.