KV’s GMP Work Plan Accepted by FDA

The FDA has accepted KV Pharmaceutical’s work plan to correct noncompliance with good manufacturing practices (GMPs), bringing the company one step closer to resuming product shipments. The company is implementing corrective measures in the plan, but it does not expect to resume shipments until the fourth quarter at the earliest, according to a Sept. 2 SEC filing. The work plan was required under a consent decree KV and the FDA reached earlier this year, allowing the company to resume production operations once its facilities are deemed compliant with GMPs.
Washington Drug Letter