Newtown-based KVK-Tech, a specialty and generic pharmaceutical products manufacturer, completed a U.S. Food and Drug Administration (FDA) inspection of its compliance with the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) on Sept. 18.
FDA investigators recorded no inspectional observations. Last year, the FDA also conducted an Adverse Drug Events inspection that yielded no observations. Back-to-back clean FDA inspections are an important regulatory milestone that signals a company’s operational and compliance strength.
“Patients, prescribers, and pharmacists rely on us to meet the highest standards, and completing this inspection with no observations reflects that commitment,” Anthony Tabasso, KVK-Tech CEO, said. “Compliance is a pillar of KVK. It is built into how we manufacture, distribute, and support every product we make, and we will continue to invest in the people and systems that uphold it.”
Opioid Analgesic REMS, a FDA-required program for opioid analgesics intended for outpatient use, is designed to support the safe prescribing, dispensing and disposal of opioids. The program includes patient medication guides, health care provider education and safe disposal resources.
KVK Tech develops and manufactures medicines that address unmet patient needs. The company is committed to building strong, lasting relationships with the largest pharmacy chains, wholesalers and distributors in the United States.