KVK-Tech Completes FDA REMS Inspection with No Observations

NEWTOWN, Pa., Sept. 22, 2026 /PRNewswire/ -- KVK-Tech, Inc., a U.S.-based manufacturer of specialty and generic pharmaceutical products, today announced that it has completed a U.S. Food and Drug Administration (FDA) inspection of its compliance with the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). The inspection concluded on September 18^th, 2026, without the issuance of a Form FDA 483, meaning FDA investigators recorded no inspectional observations. This follows a 2025 ADE (Adverse Drug Events) inspection that also yielded no observations.

The Opioid Analgesic REMS is an FDA-required program for opioid analgesics intended for outpatient use. It is designed to support the safe prescribing, dispensing, and disposal of these medicines, including through health care provider education, patient Medication Guides, and safe disposal resources.

"Patients, prescribers, and pharmacists rely on us to meet the highest standards, and completing this inspection with no observations reflects that commitment," said Anthony Tabasso, Chief Executive Officer of KVK-Tech. "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."

About KVK Tech

KVK is a leader in the development and manufacture of high-quality, FDA-approved medicines that address unmet patient needs. Founded in 2004, KVK takes pride in its ability to advance medical care and offer low-cost alternatives in response to today's healthcare challenges. All of KVK's products are made in the U.S.A. in a state-of-the-art facility in Newtown, PA. KVK is committed to maintaining its entire business operations in America, as it continues to build strong, lasting relationships with the nation's largest pharmacy chains, wholesalers and distributors.

View original content to download multimedia:https://www.prnewswire.com/news-releases/kvk-tech-completes-fda-rems-inspection-with-no-observations-302885973.html

SOURCE KVK Tech, Inc.