GMP expert Lachman Consultants is overseeing production re-start at embattled specialty drug maker KV Pharmaceutical, which is preparing for an FDA inspection required before it can resume product shipments. KV is rehiring production employees to produce test batches of drugs, a step toward what it expects to be a successful FDA inspection.
KV projects it will be shipping before the year is out, according to a report in the St. Louis Business Journal.
In March, the U.S. Department of Justice sued the drug maker to block it from manufacturing and distributing adulterated and unapproved drugs, prompted by an FDA finding of GMP noncompliance, says Reuters. The DoJ action followed a recall of several meds by KV unit Ethex, which was followed by investigations of KV by the FDA and the Security and Exchange Commission, plus lawsuits from shareholders, former employees and patients.
- here's the Journal report
- see the Reuters item
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