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This article was originally published in The Tan Sheet

Executive Summary

KV PHARMACEUTICAL EXPECTS TO RESUME SHIPPING PRODUCT BY JUNE 25 following the signing of a consent decree with FDA under which the company agrees to recondition certain seized products and to correct good manufacturing practices violations, KV said June 15. The consent decree, filed June 14 in St. Louis federal court, requires that KV engage an independent consultant to assure that its OTC and prescription products are in compliance with GMP regs and cleared by FDA. The company also must demonstrate that its St. Louis facilities are in compliance. FDA seized approximately $ 20 mil. worth of drug products in April including the OTC products phenylpropanolamine, buffered aspirin, enteric-coated aspirin and antacid tablets, and the prescription products nitroglycerin, disopyramide and potassium chloride ("The Tan Sheet" April 26, p. 15). KV has posted a $ 55,000 bond to ensure that it does not ship product prior to FDA clearance. The solid-dose OTC and prescription products were seized at the request of FDA in April after the agency found that KV had failed to adequately address observations of GMP violations made by inspectors over the course of a year. KV received a warning letter in January 1992 citing the company for failing to follow through on corrections of manufacturing deficiencies. The firm estimates its financial loss during the first quarter ending June 30 will be $ 3 mil. as a result of the FDA seizure action. However, KV noted that it recently received a $ 3 mil. cash settlement from litigation with Circa Pharmaceutical (formerly Bolar) and has $ 18 mil. in working capital as of March 31. KV indicated that an independent expert has been reviewing records and validating procedures for the products during the period of the seizure. The independent consultant hired by the company is former FDAer Joel Davis, who until recently worked in the Office of Compliance in the Drug Quality Evaluation Division. In a June 11 letter to shareholders informing them of the consent decree, KV quotes Davis as saying that the company's management and staff are "particularly competent in their areas of expertise" and that "the firm is capable of complying with [cGMPs] as stipulated" by the consent agreement. Under the plan laid out by the consent decree, KV must review records pertaining to production and testing of each drug, including lot records, stability data and analytical methods. The plan also directs the firm to review the completeness of existing validation studies and to conduct retrospective validation analyses. If these studies are insufficient to demonstrate the validity of the manufacturing processes, then the firm must perform additional validation prior to the release of any lot of drug product.

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