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Executive Summary

SCHERING LABS RECALL OF TRILAFON CONCENTRATE WAS NOT REPORTED to FDA, the agency maintained in a regulatory letter issued to the firm Aug. 23. The reg letter cites several adverse GMP findings from an inspection, completed in May, of the firm's Kenilworth, N.J. plant. The inspection was initiated in April when FDA learned of the Schering product removal action from an outside source. The FDA investigators reported confirming that Schering had "recalled" all lots of Trilafon (perphenazine) Concentrate in early April "because of instability and failure to comply with specifications prior to the five-year expiration data" without "procedures for agency notification." The regulatory letter also pointed to the April-May inspection findings that Schering had not reported a dissolution problem found in a lot of Proventil Repetabs. The FDA findings led to Schering's recall of the Proventil (albuterol) lot in July [EDITOR's NOTE: The recall is listed in the Sept. 5 "Enforcement Report" in this issue of "The Pink Sheet," T&G-14]. The FDA inspection team reported that Schering's procedures had allowed for the release of three pans of the Proventil batch even though a fourth pan from the batch, "coated at the same time, by the same person with the same solution" had been found to fail dissolution. FDA also asserted in the regulatory letter that Schering's records of problem investigations, including the Trilafon and Proventil cases, were not adequate. For instance, the FDA-483 adverse findings report on the April-May inspection states that Schering's report of the investigation into the Trilafon instability problem "was incomplete and failed to address sulfoxide release specifications, oxygen content, and other degradation products." Other inspection findings cited in the August 23 regulatory letter included lack of environmental and/or microbiological control over manufacturing areas for bulk drug substances and lack of validation of cleaning procedures in these areas. FDA also pointed out in the letter that Schering had released a batch of Vancenase (beclomethasone) Inhalers containing mold contamination. FDA acknowledged in the letter that Schering has "initiated steps to correct the deficiencies cited." The firm, in turn, noted that a detailed response to the regulatory letter was submitted to FDA during the week of Sept. 3, and it anticipates that "all" related issues will be resolved "within a short period of time."



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