FDA Shoots Down Imports From South Korean Drugmaker

September 22, 2017

The FDA blocked imports from a South Korean manufacturer of over-the-counter medical products after agency inspectors reported violations of current good management practices.

In an Aug. 31 warning letter to the manufacturer, Firson Co., the agency said the company had failed to establish procedures to prevent microbial contamination, based on an FDA inspection in November 2016. Firson’s procedures for media fills, smoke studies and sterilization were inadequate, the letter said.

The company also failed to follow up thoroughly on customer complaints, the letter said. In 2016, Firson received 32 complaints about drugs intended for the U.S. market, with reports of irritation, burning and pain from use of ointments.

In its investigation, Firson applied ointment from three lots implicated in the complaints to employees serving as test subjects, and reported that there were no problems with the products, the FDA said. The company did not evaluate its manufacturing process or test complaint lots for sterility and other quality characteristics, as it should have, the FDA said.

Firson products include burn ointments, nasal sprays, hand sanitizers, enemas and treatments for excessive sweating.

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