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ABLE LABS AMENDED PERMANENT INJUNCTION AGREEMENT

Executive Summary

ABLE LABS AMENDED PERMANENT INJUNCTION AGREEMENT resulted in a payment of $45,611 by Able parent A. L. Labs to cover the government's costs "for prosecuting the contempt action," FDA's June 23 "Enforcement Report" states. The amended agreement was filed in Newark, N.J. federal court May 25. Able was initially placed under an injunction in March 1922 after FDA brought action against the South Plainfield, N.J. company for good manufacturing practices violations ("The Pink Sheet" March 9, 1992, T&G-8). The amended order "limits...the activities at the firm" of Able's former co-owners Murty Vepuri and Paul Manning, FDA said. Both have left the firm, A. L. Labs said June 25. Although listed in the "Enforcement Report" as a "contempt action," the new court order was described by A. L. Labs as the result of an agreement between FDA and the company that did not involve a contempt finding. A. L. Labs said the modifications to the injunction order resulted from concerns raised by FDA of which A. L. Labs was unaware when it acquired Able in October ("The Pink Sheet" Sept. 21, 1992, T&G-12). FDA apparently referred its concerns to the Justice Department in March ("The Pink Sheet" March 15, T&G-7). "The stipulated order limits the individual defendants' [Manning and Vepuri] activities at the firm, sets financial penalties for violations of the agreed order, and names the manner in which the firm will be notified if a partial or complete shutdown is required," the "Enforcement Report" states. A. L. Labs said the new order does not require any manufacturing discontinuations or recalls. The departures of Manning and Vepuri were mutually agreed upon by the company and the two men, A. L. Labs said. Able is being folded into a new U.S. pharmaceuticals division of A. L. under Barre National President George Barrett, A. L. Labs added. Also covered in the June 23 "Enforcement Report" is a permanent injunction entered against Richlyn Labs of Philadelphia. "The defendants [Richlyn and owner Richard Weinberg] are permanently enjoined from the interstate shipment of any drug that is misbranded because its labeling is false or misleading," FDA said. "They are further enjoined from the interstate shipment of drugs that are adulterated because the methods used in, or the facilities or controls used for, their manufacture, processing, packing or labeling are not in conformity with current good manufacturing practice regulations." Richlyn was issued a restraining order by a Philadelphia federal court Sept. 21 and was placed under a preliminary injunction Oct. 1. The permanent injunction was issued May 25, FDA said. Richlyn has issued several recalls in recent months, including a September Class III recall of cortisone acetate because some tablets were embossed with the wrong National Drug Code number and two March 1992 recalls of methyltestosterone and dexamethasone due to use of an unapproved supplier of the active ingredient ("The Pink Sheet" April 27, 1992, T&G-11). According to FDA's "Orange Book," Richlyn markets at least 40 different drugs and vitamins.
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