A pharmaceutical manufacturer in South Dakota has settled government charges alleging violations of manufacturing standards for sterile eye drops, the Department of Justice announced Aug. 26 (United States v. Dakota Labs. LLC).
Dakota Laboratories, which no longer is in business, and the company’s owner, Charles L. Voellinger Sr., are bound by a consent decree of permanent injunction that bans them from committing violations of the Federal Food, Drug, and Cosmetic Act (FFDCA). The consent decree was filed at the same time as the government’s complaint, alleging violations of Food and Drug Administration current good manufacturing practices (cGMP) ...
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