Opinion
No. CIV-2-91-416.
December 30, 1992.
Gail L. Schmerfeld, Asst. Chief Counsel for Enforcement, Food and Drug Admin., D. Gregory Weddle, Asst. U.S. Atty., Knoxville, TN, for U.S.
Robert Van de Vurst, Jeffrey H. Benedict, Baker, Worthington, Crossley, Stansberry Woolf, Johnson City, TN, for Chem-Mix.
Bruce Shine, Kingsport, TN, and Donald E. Segal, Judith R. Brunton, Robert G. Pinco, Marshall L. Miller, Baker Hostetler, Washington, DC, for Sporicidin.
ORDER
This is a civil forfeiture action brought pursuant to the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 334, requesting that this Court seize and condemn certain "articles of device" (disinfecting agents and sterilizing solutions) because they are adulterated or misbranded. The articles were arrested on December 13, 1991, pursuant to the Court's Warrant of Arrest in Rem. On December 19, 1991, Sporicidin International, Inc. submitted a claim to the seized articles. In a letter of January 15, 1992, Chem-Mix, Inc., a contract manufacturer of Sporicidin disinfectant products, also filed a claim to the seized articles.
The case is now before the Court on motion of the United States of America for partial summary judgment. [Doc. 31]. The government would have this court rule that Sporicidin Brand Disinfectant agents and Sporicidin Cold Sterilizing Solution are adulterated under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 351(f)(1)(B), because they are Class III devices marketed without having in effect an approved premarket approval application, and are not exempt from approval under 21 U.S.C. § 360j(g). It would also have a ruling that Sporicidin Brand Disinfectant agents, Sporicidin Cold Sterilizing Solution and Sporicidin HD, are misbranded under 21 U.S.C. § 352(a), because their labeling incorrectly represents the percentage of sodium phenate present in them. The United States' motion is supported by the declarations of F. Alan Anderson, the Acting Director of the Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, and Eric B. Sheinin, a Chemist in the Division of Medical Imaging, Surgical, and Dental Drug Products, Office of Drug Evaluation, Center for Drug Evaluation and Research, United States Food and Drug Administration. Neither claimant has offered any evidence to the contrary.
Accordingly, the United States' motion for partial summary judgment is hereby GRANTED; the Court FINDS the devices adulterated and misbranded and ORDERS them condemned.