March 17, 2026 09:03 ET | Source: SK pharmteco Inc.
RANCHO CORDOVA, Calif., March 17, 2026 (GLOBE NEWSWIRE) — SK pharmteco today announced the successful conclusion of a regulatory inspection of its small molecule North America facility in La Porte, Texas.
The U.S. Food and Drug Administration (FDA) carried out a general inspection of the site from February 9 to February 12, 2026. After a thorough review of the facility’s quality systems and manufacturing operations, the FDA completed the inspection without issuing a Form 483. This “No Action Indicated” (NAI) status confirms that the site complies with the highest regulatory standards.
“The successful completion of this FDA inspection directly reflects the commitment to excellence and strong quality culture of our La Porte team,” said Kalen Minvielle, Head of Small Molecule, North America. “Maintaining an NAI status is a significant achievement that continues to highlight the strength of our systems and disciplined approach to building quality into every step of the process. It ensures our customers can continue to rely on SK pharmteco for secure, compliant, and uninterrupted manufacturing of life-enhancing medicines.”
The general inspection included thorough tours of the warehouse, manufacturing plant, and analytical laboratories. Inspectors conducted an in-depth review of the site’s procedural rigor, assessing batch records, Corrective and Preventive Actions (CAPAs), deviation and Out-of-Specification (OOS) investigations, and change controls. The agency also confirmed the integrity of the site’s equipment qualifications, purified water systems, and process and cleaning validations.
SK pharmteco actively partners with the FDA in the pursuit of excellence and continuous improvement. For example, the company recently participated in the FDA Quality Management Maturity (QMM) program, an initiative that recognizes drug manufacturers with advances beyond compliance and a culture of continuous improvement and reliability.
This successful inspection reinforces SK pharmteco’s global reputation for operational excellence in both small molecules and viral vectors, as well as its dedication to meeting the stringent requirements of regulatory agencies worldwide.
About SK pharmteco
SK pharmteco is a global contract development and manufacturing organization (CDMO) with production sites, research & development facilities, and analytical laboratories across the U.S., Europe, and South Korea. The company’s core capabilities center on small molecules, peptides, and viral vectors, providing the specialized expertise needed to bring complex therapies to market. Through these pillars, SK pharmteco supports biopharmaceutical partners of all sizes with comprehensive development and manufacturing solutions worldwide. SK pharmteco is a subsidiary of SK Inc. (KRX: 034730) (SK), the strategic investment company for SK Group, South Korea’s second-largest conglomerate.
Contact:
Keith Bowermaster, APR, CCMP
Communications Consultant
keith.bowermaster@skpt.com
