Other safety alerts
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| The United States: Federal Court enters consent decree against Florida compounder, prohibiting manufacture and distribution of drugs due to insanitary conditions |
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The US Food and Drug Administration (FDA) announces that the US District Court for the Middle District of Florida has entered a consent decree of permanent injunction that prohibits a Florida-based company (Premier Pharmacy Labs Inc.) from producing or distributing any drugs until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements.
According to the complaint, Premier Pharmacy Labs Inc. and the company’s owner, Vern A. Allen, manufactured and distributed drugs made under insanitary conditions at Premier Pharmacy’s facility, despite multiple warnings from the FDA. Premier stopped manufacturing drugs following an FDA inspection in June 2019.
The complaint alleged that Premier Pharmacy manufactured and distributed drugs, including drugs that were intended to be sterile, that were adulterated because the drugs were made under insanitary conditions and in violation of good manufacturing practice requirements under the FD&C Act. Insanitary conditions can cause a compounded drug to become contaminated or otherwise cause patient harm. According to the complaint, Premier Pharmacy also manufactured and distributed drugs that were neither approved nor exempt from approval because the products did not meet all statutory requirements for outsourcing facilities.
Please refer to the following website in FDA for details:
http://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-florida-compounder-prohibiting-manufacture-and
In Hong Kong, there is no registered pharmaceutical product manufactured by the above company. Related news was previously issued by FDA, and was posted on the Drug Office website on 12 Apr 2018 and 19 Jun 2019.
Ends/Monday, Sep 20, 2021
Issued at HKT 14:00
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