FDA makes example out of Chinese OTC manufacturer

By Ben Hargreaves

- Last updated on GMT

(Image: Getty/Milkos)
(Image: Getty/Milkos)

Related tags Fda NingBo Huize Commodity OTC

The FDA posted a public missive alongside a warning letter to a Chinese OTC drug manufacturer, highlighting the efforts it had been making to address data integrity issues.

NingBo Huize Commodity is the over-the-counter (OTC) drug manufacturer at the heart of the US Food and Drug Administration’s public announcement​ on combatting current good manufacturing practice (cGMP) violations.

The Chinese OTC drug manufacturer was visited by inspectors at its Zhejiang facility in March 2019. During the visit, the company’s quality control unit provided the agency with documents that company officials admitted were falsified “for the purpose of [the] inspection.”

The falsified documents included cleaning validation reports, batch records for multiple drug product, and annual product reviews.

As a result of the FDA’s findings, the agency concluded that all products produced by Ningbo would be considered adulterated.

The company agreed with the FDA to instigate a voluntary recall of its products, and is currently placed under an import alert, effective as of June of this year, preventing any further entry of its products onto the US market.

NingBo produces OTC products, including sunscreen, lip balm, and hand sanitizer.

The Center for Drug Evaluation and Research, which issued the warning letter to NingBo, has already issued 39 warning letters so far in 2019, but the step of the FDA issuing a public statement, along with comment by acting FDA commissioner, Ned Sharpless, is unusual.

In a statement, Sharpless said, “In recent years, the FDA has focused additional resources on efforts to prevent, uncover and combat data integrity lapses. We’ve focused comprehensive new efforts on these risks, both through our global inspections program as well as providing updated guidance, and to train our staff on identifying concerns related to data integrity.”

In addition, the agency used the public announcement to warn manufacturers to put appropriate quality control systems in place, suggesting that “when the agency finds manufacturers who are not complying with data integrity requirements, the FDA takes action against those manufacturers’ practices and works to bring them into compliance.”

The agency linked to its recently updated guidance​ on how to ensure data integrity and compliance with cGMP when manufacturing drug products.

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