其 他 安 全 警 示
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| The United States: Federal court enters consent decree against Pharmasol for distributing adulterated drugs (English only) |
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The US Food and Drug Administration (FDA) announces that the US District Court for the District of Massachusetts has entered a consent decree of permanent injunction ordering Pharmasol Corporation and President Marc L. Badia to stop distributing drugs until the company complies with the Federal Food, Drug, and Cosmetic (FD&C) Act and other requirements listed in the consent decree. According to the complaint, which was filed along with the consent decree by the US Department of Justice, Pharmasol and Badia unlawfully distributed adulterated drugs, meaning they do not comply with manufacturing quality requirements within the United States marketplace.
Pharmasol manufactures and distributes over-the-counter drugs, as well as human and animal prescription drugs such as topical corticosteroids and inhalant anesthetics. Pharmasol is under contract with multiple pharmaceutical companies.
According to the complaint, the defendants violated federal law under the FD&C Act by introducing drugs into interstate commerce that fail to comply with current good manufacturing practice requirements; therefore, these drugs are adulterated.
The most recent inspection of the company’s facilities in 2022 found the majority of the inspectional observations repeated those found in past FDA inspections and detailed in a 2019 warning letter. Violations mentioned in the complaint include failure to:
- fully investigate errors and ensure that the responsibilities and procedures applicable to the quality control unit are in writing and fully followed, including reporting drug defects to customers;
- follow written procedures that describe the handling of written and oral complaints regarding a drug product; and,
- adequately clean and maintain equipment.
In the 2019 warning letter, the agency cited customer complaints of product leakage out of the container and the company’s failure to investigate. Despite repeated warnings, the company and Badia continued to violate the law.
The consent decree prohibits Pharmasol and Badia from directly or indirectly manufacturing, preparing, processing, packing, repacking, receiving, labeling, holding and/or distributing any drug, at or from their facilities, unless and until defendants meet certain requirements to ensure that Pharmasol operates in compliance with the FD&C Act, the FDA’s regulations, and the decree, and defendants receive written notice from the FDA that they appear to be in compliance with these requirements.
Please refer to the following website in FDA for details:
http://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-pharmasol-distributing-adulterated-drugs
In Hong Kong, there is no registered pharmaceutical product manufactured by Pharmasol Corporation.
Ends/Friday, Dec 15, 2023
Issued at HKT 15:30
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