FDA Warns Korean OTC Drugmaker Using Noncompliant Contract Manufacturer

Posted 12 December 2017 | By Zachary Brennan 

FDA Warns Korean OTC Drugmaker Using Noncompliant Contract Manufacturer

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Seoul, South Korea-based over-the-counter (OTC) drug manufacturer Seindni Co. for current good manufacturing practice (CGMP) violations and labeling concerns.

The warning letter notes that the firm "lacks an adequate quality unit" and uses contract manufacturers for its OTC drugs distributed to the US, but during FDA’s inspection, Seindni "confirmed that your contract manufacturers do not make your OTC drug products in conformance with drug CGMP."

For example, FDA noted, the company has 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."

On 23 August 2017, FDA placed the firm on Import Alert 66-40.

FDA also found that some of the company’s labels for sunscreen and skin protectant OTC drug products did not comply with all requirements of federal law and FDA regulations.

In addition to the Seindni warning letter, FDA on Tuesday released another warning letter sent to Arco Globus Trading, which is illegally marketing and distributing a taurine and guarana powder product, known as Coko Loko, promoted to be snorted (inhaled intranasally), and "Legal Lean Syrup," a product that contains the active pharmaceutical ingredient doxylamine, which is not present in the product labeling.

Seindni Co., Ltd. 12/5/17

Arco Globus Trading LLC 12/11/17


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