FDA conducted an initial inspection of Guardian Pharmacy in 2016, resulting in a warning letter. The FDA subsequently received reports concerning at least 43 patients who were administered eye injections of a drug compounded by Guardian Pharmacy.
These patients reported symptoms such as vision impairment, poor night vision, and a significant reduction in visual fields.
In March 2019, The Department of Justice filed a complaint against Guardian Pharmacy, alleging that the company manufactured and distributed purportedly sterile drugs that were made under unsanitary conditions and in violation of current manufacturing practice requirements under the Federal Food, Drug, and Cosmetics Act.
As part of the injunction, Guardian Pharmacy and its owner are forbidden from manufacturing, processing, or distributing sterile drugs until FDA determines that the company has complied with specific measures.
In addition to operating in Texas, the company is licensed in other states including Arizona, Colorado, Iowa, and Oklahoma.
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