Zenith Labs

Executive Summary

FDA inspection of the firm's Northvale, N.J. manufacturing plant completed on Aug. 22 resulted in a 17-page FD-483 list of current good manufacturing practice citations. FDA requested a preliminary injunction against Zenith in November; a hearing is set for Dec. 23 ("The Pink Sheet" Nov. 25, p. 7). Process validation, a key issue involved in recent FDA preliminary injunction actions against other generic manufacturers including West-Ward Pharmaceuticals, Able Labs and Biopharmaceutics, was also raised during FDA's inspection of Zenith's Northvale plant.