其 他 安 全 警 示
|
| |
| The United States: FDA warns company for putting consumers at risk with drug manufacturing data integrity violations (English only) |
| |
The US Food and Drug Administration (FDA) announces that it posted a warning letter to Ningbo Huize Commodity Co., an over-the-counter (OTC) drug manufacturer, for significant current good manufacturing practice (CGMP) violations, including data integrity issues.
The warning letter issued to Ningbo Huize details a failure to have adequate quality control mechanisms in place. The company provided FDA investigators multiple documents that were falsified, including the cleaning validation reports and batch production and control records for multiple drugs. The firm also provided records showing they performed the required periodic reviews of their operation to assure quality, which they later admitted were also falsified. These CGMP violations cause all drugs manufactured by Ningbo Huize to be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA also considers the adulterated products to be misbranded because the product labels did not include all the required information and directions for use. Following the inspection in Mar 2019, the FDA placed the company on import alert in Jun 2019 to prevent their drugs from entering the US market. The company has also agreed to voluntarily recall drugs.
Please refer to the following website in FDA for details:
http://www.fda.gov/news-events/press-announcements/fda-warns-company-putting-consumers-risk-drug-manufacturing-data-integrity-violations
In Hong Kong, there is no registered pharmaceutical product manufactured by the above company.
Ends/Wednesday, Aug 21, 2019
Issued at HKT 15:00
|
| |
