Jul 12

FDA Seeks Injunction against Company for Misbranding Drug Products

On June 25, 2014, the U.S. Department of Justice (“DOJ”), in response to a request made by the U.S. Food and Drug Administration (“FDA”), filed a complaint seeking a permanent injunction against Laclede, Inc. of Rancho Domingo California and the Company’s president, Michael A. Pellico. The injunctive relief, which was sought in the U.S. District Court for the Central District of California, related to Laclede’s illegal distribution of over-the-counter (OTC) vaginal drug products that did not have the required FDA approval. News pertaining to this action can be found here.

The unapproved products that were subject to the complaint against Laclede include: Luvena Prebiotic Vaginal Moisturizer and Lubricant; Luvena Prebiotic Enhanced Personal Lubricant; Luvena Prebiotic Feminine Wipes; and Luvena Prebiotic Daily Therapeutic Wash. Two separate inspections conducted at the company’s Rancho Domingo facility, dated June 19 and June 27, 2012, found that the products listed did not have proper identification and strength listings for the active ingredients of those products, in violation of Title 21, Code of Federal Regulations, Parts 211 [21 CFR §211.165(a)] of the Act. Subsequent to the inspections the FDA sent a warning letter, dated February 14, 2013, which informed the Company that they both failed to take corrective actions regarding their testing procedures, and that based on the current labeling and marketing of the products, the FDA found the products to be classified as “unapproved and misbranded” drugs.

Based on the claims made by the Company on its product labels, inserts and website, the products were found to be in violation of the Federal Food, Drug and Cosmetic Act. Discovered during facility inspections and later the subject of a warning letter, these deficiencies were not corrected, despite several notifications from the FDA. Accordingly, the present action was taken against Laclede, as the Company failed to take corrective actions in response to numerous warnings by the FDA. Had the company heeded the repeated warnings posed to them by the FDA and made appropriate changes to the branding of their products, they may have been able to avoid further action. Any company that has received notice regarding the misbranding of products should take appropriate action as soon as possible to reduce the risk of further penalties.

If you have any questions about how you can maintain compliance with FDA regulations, please contact us at contact@giannamore-law.com.

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