The Opioid Analgesic REMS program mandates that pharmaceutical companies implement rigorous safety protocols for outpatient medications, including educational outreach for healthcare providers and standardized patient guidance. By recording zero inspectional observations, KVK-Tech demonstrated that its current manufacturing and distribution systems align with these federal safety requirements.
In section Releases
KVK-Tech Clears FDA Opioid Compliance Review Without Citations
Federal regulators concluded an inspection of KVK-Tech’s Newtown facility on September 18, finding no deviations in the company's adherence to the Opioid Analgesic Risk Evaluation and Mitigation Strategy. The clean report marks the second consecutive year the manufacturer has passed a high-level FDA audit without receiving a Form 483.
Anthony Tabasso, CEO of KVK-Tech, noted that the result reinforces the company’s internal focus on regulatory compliance. This latest audit follows a successful 2025 review of the company’s Adverse Drug Events reporting processes. Founded in 2004, the Pennsylvania-based manufacturer continues to maintain its entire production line within the United States, supplying generic alternatives to major pharmacy chains and wholesalers nationwide.
Comments (0)
No comments yet. Be the first!