K-V Pharmaceutical Company announced today that it has received notice from the FDA of the successful completion of an inspection of the company’s facilities and approval to return its first product to market. Under the company’s Consent Decree, successful FDA inspections of the company’s quality systems, processes and facilities are expected to be required before K-V is permitted to resume manufacturing and shipment of particular products.
During the week of August 16, 2010, the FDA undertook an inspection of the Company’s quality systems, manufacturing processes and facilities focusing on the first product dosage form for reintroduction by the Company into the marketplace. The inspection was successfully completed.
The Company received notification from the FDA on September 8, 2010 of approval to ship into the marketplace the first product approved under the consent decree, i.e. Potassium Chloride. The Company expects that initial shipments of its Micro-K 10mEq and Micro-K 8mEq will begin the week of September 13, 2010. The FDA is expected to conduct additional inspections with respect to other company products before deciding whether other products may be manufactured and marketed.
Greg Divis, President of Ther-Rx Corporation and Interim President and Chief Executive Officer of K-V Pharmaceutical Company, stated, “Today marks a significant milestone in our efforts to restore business operations at K-V. The successful FDA inspection of our facilities and approval of our return to market demonstrates our hard work and commitment to meeting and sustaining current Good Manufacturing Practices (“cGMP”) requirements. We are committed to continuing to move K-V through further successful inspections and to obtain additional product approvals from the FDA.”