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Regulatory Focus™ > News Articles > 6 > FDA Warns Korean, Australian Drugmakers, Online Opioid Sellers

FDA Warns Korean, Australian Drugmakers, Online Opioid Sellers

Posted 05 June 2018 | By Michael Mezher 

FDA Warns Korean, Australian Drugmakers, Online Opioid Sellers

The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to drugmakers in Australia and Korea over good manufacturing practice (GMP) violations and warned the operators of more than 50 websites for illegally selling unapproved opioids.

The agency also warned online medical equipment supplier Tiger Medical for selling Alere Determine HIV-1/2 Ag/Ab Combo test kits without ensuring that buyers are a physician or healthcare practitioner. FDA says the test kits are classified only for use by clinical laboratories that have an adequate quality assurance program and are only to be sold by prescription or order by a healthcare practitioner.

Kolmar Korea

In its warning letter to Jeonui-Myeon, Korea-based drugmaker, FDA cites the company for two GMP violations observed during a four-day inspection September 2017.

According to FDA, Kolmar failed to investigate out-of-specification (OOS) results for certain lots of an over-the-counter (OTC) cream and instead retested and invalidated the OOS results without justification.

FDA also says the company failed to follow its own written procedures for document control, which require quality control unit approval for discarding records.

“Our investigator observed documents and records, including batch production records, certificates of analysis, and laboratory worksheets, that were torn and discarded without documented quality unit approval,” FDA writes.

IDT Australia

FDA’s warning letter to IDT Australia comes as a result of an inspection of the firm’s Boronia-based facility in December 2017 and details GMP issues related to the company’s active pharmaceutical ingredients (API) and finished drugs.

FDA says the company failed to adequately investigate OOS results for a batch of one of its APIs. While the company determined a root cause of the OOS result, it did not implement a corrective action to address the issue and released subsequent batches of that API.

In another instance, FDA says the company determined the cause of an OOS result without adequate evidence.

For finished drugs, FDA cites IDT for failing to follow laboratory control mechanisms and failing to ensure laboratory records include complete data.

In one case, FDA says the company ran three consecutive failed tests of an exhibit batch of a product before accepting the passing result from a fourth test. FDA says the results from the failed tests were not included in the data package that was sent to the company’s quality unit or in its application to FDA for the product.


FDA also announced that it sent warning letters to nine online networks operating some 53 websites for illegally selling unapproved and misbranded versions of opioids such as tramadol and oxycodone.

In the warning letters FDA demands that the companies immediately stop selling the illegal drugs and comply with the agency’s requests within 10 working days.

“The internet is virtually awash in illegal narcotics,” said FDA Commissioner Scott Gottlieb, noting that FDA will be hosting a summit on 27 June to encourage voluntary action by stakeholders from legitimate internet stakeholders such as social media platforms, domain name registries and online marketplaces against firms illegally selling opioids online.

The nine networks FDA sent warning letters to include AnonShop, Eassybuyonline, Instabill ECS-Rx, Medstore.biz, One Stop Pharma, RemedyMart, RxCash.Biz, TramadolHub and XLPharmacy.

Warning Letters: Kolmar Korea, IDT Australian, Tiger Medical

Opioid Statement

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