NEWTOWN, PA — KVK-Tech Inc. completed a U.S. Food and Drug Administration inspection of its opioid risk-management compliance on Sept. 18 without receiving a Form FDA 483, indicating investigators recorded no inspectional observations at the Newtown pharmaceutical manufacturer.
The inspection examined KVK-Tech’s compliance with the Opioid Analgesic Risk Evaluation and Mitigation Strategy, or REMS, an FDA-required program covering opioid analgesics intended for outpatient use.
A Form FDA 483 is issued when investigators identify conditions they judge may constitute violations of federal food and drug law or related requirements. No such form was issued following the inspection.
The result follows an adverse drug events inspection in 2025 that also concluded without observations, according to KVK-Tech.
The opioid REMS program is intended to reduce risks associated with opioid analgesics through measures that include healthcare provider education, patient Medication Guides and resources for safe drug disposal.
“Compliance is a pillar of KVK,” Chief Executive Officer Anthony Tabasso said. “It is built into how we manufacture, distribute, and support every product we make.”
KVK-Tech develops and manufactures specialty and generic pharmaceuticals at its Newtown facility. Founded in 2004, the company manufactures its products in the United States and supplies pharmacy chains, wholesalers and distributors.
