FDA Issues Warning Letter to OTC Drug Manufacturer For Data Integrity Concerns

The FDA has published a warning letter sent to Ningbo Huize Commodity Co., an over-the-counter drug manufacturer, citing significant current good manufacturing practice (CGMP) violations, including data integrity issues.¹

The warning letter specified a failure to have adequate quality control mechanisms in place and the provision of falsified documents to FDA investigators.¹ According to the agency, falsified documents included cleaning validation reports, and batch production and control records for multiple drugs. A statement issued by the FDA said the company also admitted to falsifying records showing that they performed the required periodic reviews of their operation to assure quality.

As a result of these CGMP violations found during the FDA inspection in March 2019, all drugs manufactured by Ningbo Huize are adulterated under the Federal Food, Drug, and Cosmetic Act. The FDA statement added that the adulterated products are also considered to be misbranded because the product labels did not include all the required information and directions for use. These products include sunscreen lotions.²

In response to the FDA’s original accusation of falsified documents, Ningbo Huize representatives provided the agency with further CGMP documents in writing. Considering the company’s history of falsified documents, however, the FDA letter expressed concern regarding the document’s validity.

“Your response is inadequate because you failed to fully review the scope of your deficiencies, and provide evidence that you have comprehensively remediated your systems, and to implement procedures and programs that ensure ongoing control over your drug manufacturing operation,” the letter read.²

In response to the letter, the FDA requested several comprehensive assessments and remediation plans, in addition to a full summary of data integrity assessments performed by a third-party consultant. The letter requested this information within 15 working days.

References

• FDA warns company for putting consumers at risk with drug manufacturing data integrity violations. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-warns-company-putting-consumers-risk-drug-manufacturing-data-integrity-violations. Published August 20, 2019. Accessed August 21, 2019.
• Center for Drug Evaluation and Research. Ningbo Huize Commodity Co., Ltd. -581345- 08/02/2019. U.S. Food and Drug Administration. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ningbo-huize-commodity-co-ltd-581345-08022019. Published August 20, 2019. Accessed August 21, 2019.