Sterling Winthrop
Executive Summary
Receives Sept. 12 FDA warning letter concerning an Aug. 7 inspection of Sterling's Barceloneta, Puerto Rico facility. Among other charges, the letter states that Sterling has "failed to thoroughly investigate the presence of metal particles" in a lot of Neo Synephrine and "the potential presence of such particles in other lots." The company claims that it responded to the FD-483 issued after the inspection within the deadline and that the response and the warning letter crossed in the mail. Sterling says the Neo Synephrine discoloration, which prompted a May 17 recall of lot B325fl ("The Pink Sheet" July 24, T&G-15), was an isolated incident and that the company has resolved all of the problems cited by FDA. . . .