An inspection thumbs-up from the FDA last week for KV Pharma's Micro-K manufacturing ops marks a milestone in the drugmaker's GMP-violations comeback. The approval gives KV the go-ahead to produce Micro-K, a treatment for low blood potassium.
The approval follows a mid-August inspection that encompassed quality systems, manufacturing processes and facilities, all of which passed FDA muster. "The inspection was successfully completed without the issuance of a FDA 483," the drugmaker trumpets in an announcement. It expects to begin shipping Micro-K this week.
But it's still a partial comeback for KV at this point. More FDA inspections lie ahead for other products. And the outcomes of those inspections will determine whether the agency gives the go-ahead for their manufacturing and marketing.
The company's troubles date from the 2008 recalls of products made at a Missouri generics facility. The recalls were followed by the FDA's seizure of $24 million in products and its shutdown of the plant, as reported.
- here's the KV release
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