In separate warning letters posted online Sept. 4, the Food and Drug Administration told Infupharma LLC and DPT Lakewood LLC that FDA inspections revealed the companies had not complied with current good manufacturing practices (cGMPs).
FDA said that as a result of the inspections, products made by the companies were considered “adulterated” under the Federal Food, Drug, and Cosmetic Act.
The agency also warned Infupharma that its repackaging practices for the cancer drug Avastin and the weight loss drug HCG “exceed the traditional practice of pharmacy” and these repackaged products are considered unapproved new drugs.
Infupharma Letter.
In a letter ...
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