KV Pharmaceuticals announced on September 10 that it will restart shipment of its potassium chloride capsule product Micro-K after a successful inspection in August of its St. Louis facility and a letter from FDA this month giving the firm permission to resume manufacturing and distribution of the product.
KV, a manufacturer of pharmaceutical ingredients and generic drugs, has been operating under a consent decree for eighteen months. Under the terms of the agreement, successful FDA inspection of the company’s quality systems, processes and facilities are required before the firm is able to resume manufacturing and shipment of particular products.
In announcing its resumption of Micro-K distribution, KV explained that FDA “is expected to conduct additional inspections with respect to other company products before deciding whether other products may be manufactured and marketed.”
FDA’s enforcement action at KV reflected both GMP problems and the manufacturing of products that do not have the required new drug approval or meet OTC monograph standards – a frequent linkage in FDA warning letters and injunctions over the last few years. [Editor’s note: The IPQ May/June 2009 Report provides an in-depth analysis of this FDA enforcement trend and its impact on KV and other implicated drug companies.]
The March 2009 consent decree specifies that it will remain in place until KV sustains continuous cGMP compliance and meets new drug approval requirements for six years.
[More on the history of KV’s compliance problems with FDA and links to relevant documents are available for subscribers here.]
