Korean Pharmaceutical Manufacturer Receives FDA Warning Letter

Seoul-based pharmaceutical manufacturer, Seindni Co. Ltd received a warning letter from the US Food and Drug Administration (FDA) after the regulator found that they mislabelled certain over-the-counter (OTC) skin products and failed to follow Good Manufacturing Practise (GMP). Part of the FDA’s concerns centered around Seindni’s use of a contract manufacturer, which they found to be noncompliant with a number of manufacturing requirements.

The contract manufacturer did not conduct tests to confirm the strength and identity of active ingredients in the OTC drug products prior to distributing them. In addition, Seindni had an inadequate quality unit in place which would regularly release products over the phone without documenting product quality.

“You utilize contract manufacturers to manufacture your over the counter (OTC) drug products distributed to the United States,” said the warning letter to Seindni. “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. You do not have procedures covering your batch release process, and your quality unit lacks documentation to demonstrate acceptability of batch manufacturing and product quality.”

As outsourcing continues to be a growing trend in the pharmaceutical industry as a whole, drugmakers often use contract manufacturers to produce their active ingredients or their final product. However, the company responsible for distributing the drug product is also held accountable for the actions of their contract manufacturing partner when it comes to the safety and quality of drugs released to market.

This isn’t the first time Seindni has been cited by the regulator. In May, the FDA sent the company a Form 483 after identifying several violations during a recent inspection. Seindni failed to respond to that warning letter, prompting the FDA to prevent any pharmaceutical products manufactured by the company from entering the US.

Seindni is required to respond to the FDA’s warning letter within 15 working days with details of corrective actions the company has taken to fix the issues.