FDA SEEKING PRELIMINARY INJUNCTIONS AGAINST WEST-WARD, ABLE LABS AND ZENITH FOR GMP VIOLATIONS; BIOPHARMACEUTICS SIGNS CONSENT DECREE ON GMPs

FDA is pursuing preliminary injunctions against three generic firms: West-ward Pharmaceuticals, Able Labs and Zenith Labs, in a recent crackdown on good manufacturing practice (GMP) violations. Another generics firm, Biopharmaceutics, has signed a consent decree to correct GMP problems. The agency filed a request for a preliminary injunction against West-ward Pharmaceuticals (Eatontown, N.J.) on Nov. 8 in Trenton federal court. West-ward said that its GMP problems, which primarily involve process validation deficiencies, are carryovers from previous management. A hearing is scheduled for Dec. 2. The company said it hopes to settle with FDA. On June 19, Moore Medical agreed to sell West-ward to Hikma Investment Co. After Moore Medical purchased West-ward in 1988, the company was shut down by internal auditors and attorneys because of discrepancies in recordkeeping. In late 1990, FDA sent West-ward a regulatory letter warning that unless necessary corrections were made the agency was prepared to pursue administrative or legal measures to assure that the corrections occurred. At the time, Rep. Dingell's (D-Mich.) Energy & Commerce/Oversight Subcommittee made inquiries into the firm's compliance problems ("The Pink Sheet" Dec. 24, 1990, p. 5). On July 30, soon after purchasing West-ward, the new company officials held a meeting with FDA's Newark District Office to discuss the firm's GMP problems. On July 31, FDA initiated an inspection of West-ward's facilities, which lasted until Aug. 14. West-ward said that it believes the company corrected a majority of violations, including validation and testing methods cited in an FDA-483, that resulted from that inspection. The company added that it asked FDA several weeks ago to reinspect its facilities. Since the new management took over, West-ward said it has completed process validation on 90% of its products. FDA also recently submitted a complaint in Newark federal court for an injunction against South Plainfield, N.J.-based Able Labs. The FDA action stems from an inspection of the firm conducted between June and August. Able said a six-page FD-483 issued following the inspection contains 12 items centering on documentation and validation concerns. Able said it has been meeting with the agency's Newark District Office to resolve the issues, and that manufacturing and shipping operations are continuing as usual. A hearing on the injunction request has been postponed from Dec. 9 until early February pending ongoing discussions. FDA is seeking to prevent Zenith Labs from continuing manufacturing and shipping. The agency recently filed a request in Newark federal court for a preliminary injunction against the firm for GMP violations. A hearing in the case is set for Dec. 23. Zenith received a warning letter Oct. 4 for GMP deviations involving the production of the antibiotic cephradine at its St. Croix, U.S. Virgin Islands facility, which is operated by the firm's subsidiary Pralex Corp. ("The Pink Sheet" Nov. 11, T&G-5). The letter resulted from an Aug. 26-Sept. 10 inspection. Biopharmaceutics, in a Nov. 19, release said that "under the decree, the company's own independent . . . consultant shall verify to FDA that the company is in full compliance with [GMPs]." The firm's operations were shut down after FDA won a temporary restraining order Nov. 1 ("The Pink Sheet" Nov. 11, T&G-6). Biopharmaceutics said that the TRO was "a direct result" of activities by three former employees, who, while employed with the firm, ran a business as an intermediate manufacturer for Biopharmaceutics' raw material supplier. Biopharmaceutics also must provide FDA with "a protocol for validating the company's blending methods" and allow the agency to inspect facilities to confirm compliance before operations can resume. FDA will clear products based on the validation data. The company plans to present 12-15 products, which represent 70% of sales, for FDA's first inspection, and another 12-15 products for the second inspection.